AURIS HEALTH, INC. MON-000709 Monarch Advanced Imaging Accessory Kit

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.

Included: PAL LipoTower Aspiration System Cart Microaire 5020 650 Pal Power Assisted Lipo PAL-650 Liposculptor Handpiece. SN8660

The EPF-1 Thunderbeat is part of the Olympus THUNDERBEAT surgical tissue management system, comprising the ESG-400 generator, the USG-400 generator, a communication cable, and monopolar single and dual footswitches.

The EPF-1 Thunderbeat is part of the Olympus THUNDERBEAT surgical tissue management system, comprising the ESG-400 generator, the USG-400 generator, a communication cable, and monopolar single and dual footswitches. *Please note that the USG-400 on this listing has a cracked screen. However, the unit is 100% functional. *

AEH-4 Electrohydraulic Lithotripsy System

Fiberoptic Light Cable (Wolf Scope and Stryker Light Source Fittings, Snap-On)

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.

Included: PAL LipoTower Aspiration System Cart Microaire 5020 650 Pal Power Assisted Lipo PAL-650 Liposculptor Handpiece. SN8660