Philips Medical Systems Hsg 989803151771 NOUN

Intended Use: FORUM is a software system intended for use in storage, management, processing, and display of patient, diagnostic, video and image data and measurement from computerized diagnostic instruments or documentation systems through networks. It is intended to work with other FORUM applications.FORUM is intended for use in review of patient, diagnostic and image data and measurement by trained healthcare professionals.

CER-S is stand-alone software medical device, providing advanced solutions for importing, analyzing, editing, reviewing and generating clinical reports related to digital continuous ECG recordings (Holters). CER-S does not carry out an automated interpretation of the ECG data.

IMAGEXL XRAY SOFTWARE VERSION 4 BASE

Airsonett is based on the Temperature controlled Laminar Airflow (TLA) technology. The air from the room enters the Airsonett and passes a filter that captures allergens and other particles. The filtered air is cooled to slightly below the ambient room temperature and is supplied with a low velocity from the air supply nozzle. Since the filtered air is slightly cooler, and therefore heavier than the surrounding air, the filtered air will descend slowly from the air supply nozzle by means of gravity in a laminar manner (non-turbulent). This descending colder air counteracts the body convection, displaces the allergen load in the breathing zone and thus dramatically reduces the level of inhalant allergens for the patient all through the night.

AliMed® Patient Roller Long: 14"W x 67"L, 13 lbs.

The Test of Variables of Attention (T.O.V.A.) kit contains the hardware and software necessary to install and administer the T.O.V.A. continuous performance test. The T.O.V.A. provides healthcare professionals with objective measurements of attention and inhibitory control. The visual T.O.V.A. aids in the assessment of, and evaluation of treatment for, attention deficits, including attention-deficit/hyperactivity disorder (ADHD). The auditory T.O.V.A. aids in the assessment of attention deficits, including ADHD. T.O.V.A. results should only be interpreted by qualified professionals.

First Aid Kit Wihout Drug (Content : Adhesive bandages in a variety of different sizes and shapes + Non-adherent sterile Gauze Pad + Cleansing wipe (with alcohol)) This type of convenience kit, as listed in the guidance above, is under enforcement discretion, and does not require a premarket notification (510(k)) to market if it meets all criteria in the guidance.

K-WIRE TROCAR POINT BOTH ENDS .062 X 4

Neurofeedback Software

ImPACT is intended for use as a computer-based neurocognitive test battery to aid in the assessment and management of concussion. ImPACT is a neurocognitive test battery that provides healthcare professionals with objective measure of neurocognitive functioning as an assessment aid and in the management of concussion in individuals ages 12-80.

Intended Use: FORUM is a software system intended for use in storage, management, processing, and display of patient, diagnostic, video and image data and measurement from computerized diagnostic instruments or documentation systems through networks. It is intended to work with other FORUM applications.FORUM is intended for use in review of patient, diagnostic and image data and measurement by trained healthcare professionals.

CER-S is stand-alone software medical device, providing advanced solutions for importing, analyzing, editing, reviewing and generating clinical reports related to digital continuous ECG recordings (Holters). CER-S does not carry out an automated interpretation of the ECG data.

IMAGEXL XRAY SOFTWARE VERSION 4 BASE

Airsonett is based on the Temperature controlled Laminar Airflow (TLA) technology. The air from the room enters the Airsonett and passes a filter that captures allergens and other particles. The filtered air is cooled to slightly below the ambient room temperature and is supplied with a low velocity from the air supply nozzle. Since the filtered air is slightly cooler, and therefore heavier than the surrounding air, the filtered air will descend slowly from the air supply nozzle by means of gravity in a laminar manner (non-turbulent). This descending colder air counteracts the body convection, displaces the allergen load in the breathing zone and thus dramatically reduces the level of inhalant allergens for the patient all through the night.