510(k) Report

Devices descending from K090398

3 later devices reach Provent Professional Sleep Apnea Therapy through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K102404Provent Professional Sleep Apnea Therapy (Provent 80); Provent Professional Sleep Apnea…Ventus Medical, Inc.20102—
+2K191728ULTepap Expiratory Positive Airway Pressure (EPAP) DeviceBryggs Medical, LLC20200—
+2K180619BongoInnomed Healthscience, Inc.20181—