FDA 510(k) Applications for Medical Device Product Code "OHP"
(Expiratory Resistance Valve, Intranasal, For Obstructive Sleep Apnea)

FDA 510(k) Number Applicant Device Name Decision Date
K191728 Bryggs Medical, LLC ULTepap Expiratory Positive Airway Pressure (EPAP) Device 02/21/2020
K180619 InnoMed Healthscience, Inc. Bongo 08/16/2018
K071560 VENTUS MEDICAL, INC. PROVENT NASAL DILATOR, MODEL BR2 02/08/2008
K090398 VENTUS MEDICAL, INC. PROVENT PROFESSIONAL SLEEP APNEA THERAPY 04/03/2009
K102404 VENTUS MEDICAL, INC. PROVENT PROFESSIONAL SLEEP APNEA THERAPY (PROVENT 80); PROVENT PROFESSIONAL SLEEP APNEA THERAPY (PROVENT 50) 12/02/2010


Search | Companies | Product Codes | Device Names | Contacts | Applications | Decisions | Contact