AEROGEN LIMITED AG-AS5000-PH-US Aerogen Solo Nebulizer System

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.

RhodoLED® XL is a red light emitting LED lamp which is used exclusively in combination with Ameluz® (aminolevulinic acid hydrochloride) gel, 10% for lesion-directed and field-directed treatment of actinic keratoses (AKs) of mild-to-moderate severity on the face and scalp.

BF-RhodoLED® is a red light emitting LED lamp which is used exclusively in combination with Ameluz® (aminolevulinic acid hydrochloride) gel, 10% for lesion-directed and field-directed treatment of actinic keratoses (AKs) of mild-to-moderate severity on the face and scalp.

Concentriq AP-Dx is a web-based, software-only device that is intended to aid pathology professionals in viewing, interpretation and management of digital whole slide images (WSI) of scanned surgical pathology slides prepared from formalin-fixed, paraffin-embedded (FFPE) tissue obtained from Hamamatsu NanoZoomer S360MD Slide scanner. It aids the pathologist in the review, interpretation, and management of pathology slide digital images used to generate a primary diagnosis.

CIRCUIT,UNIVERSAL,IPPB

Mobile C-arm

solo Digital Clinical Scale, Mechanical Height Rod, 550 lb x 0.2 lb / 250 kg x 0.1 kg

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.

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.

RhodoLED® XL is a red light emitting LED lamp which is used exclusively in combination with Ameluz® (aminolevulinic acid hydrochloride) gel, 10% for lesion-directed and field-directed treatment of actinic keratoses (AKs) of mild-to-moderate severity on the face and scalp.

BF-RhodoLED® is a red light emitting LED lamp which is used exclusively in combination with Ameluz® (aminolevulinic acid hydrochloride) gel, 10% for lesion-directed and field-directed treatment of actinic keratoses (AKs) of mild-to-moderate severity on the face and scalp.

Concentriq AP-Dx is a web-based, software-only device that is intended to aid pathology professionals in viewing, interpretation and management of digital whole slide images (WSI) of scanned surgical pathology slides prepared from formalin-fixed, paraffin-embedded (FFPE) tissue obtained from Hamamatsu NanoZoomer S360MD Slide scanner. It aids the pathologist in the review, interpretation, and management of pathology slide digital images used to generate a primary diagnosis.