Freudenberg Medical, LLC PK 2100 InHealth Technologies; Blom-Singer

Post-Operative Care Kit with 10/55 Tube & EasyFlow HME

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.

Post-Operative Care Kit with 12/55 Tube & ClassicFlow HME

Post-Operative Care Kit with 10/55 Tube & ClassicFlow HME

Post-Operative Care Kit with 10/55 Tube & ClassicFlow HME & Electrolarynx

Post-Operative Care Kit with 10/55 Tube & ClassicFlow HME & Voice Prosthesis

Post-Operative Care Kit with 9/55 Tube & EasyFlow HME

Post-Operative Care Kit with 12/55 Tube & EasyFlow HME

Post-Operative Care Kit with 10/55 Tube & EasyFlow HME

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.