510(k) Report

Devices descending from K983920

12 later devices reach Ems Peep Valves- Adjustable through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K071560Provent Nasal Dilator, Model BR2Ventus Medical, Inc.200810—
+1K053466Hsiner ResuscitatorHsiner Co., Ltd.20060—
+2K111549Attune Sleep Apnea SystemApnicure, Inc.20125—
+2K102404Provent Professional Sleep Apnea Therapy (Provent 80); Provent Professional Sleep Apnea…Ventus Medical, Inc.20102—
+2K090398Provent Professional Sleep Apnea TherapyVentus Medical, Inc.200931
+3K191728ULTepap Expiratory Positive Airway Pressure (EPAP) DeviceBryggs Medical, LLC20200—
+3K180619BongoInnomed Healthscience, Inc.20181—
+3K132003Winx Sleep Therapy SystemApnicure, Inc.20140—
+3K130538Winx Sleep Therapy SystemApnicure, Inc.20132—
+3K122130Winx Sleep Therapy SystemApnicure, Inc.20123—
+4K193460The iNAP One Sleep Therapy SystemSomnice, Inc.20201—
+5K220907The iNAP One Sleep Therapy SystemSomnics, Inc.20230—