BIPAP A 40 VENTILATORY SUPPORT SYSTEM

Ventilator, Continuous, Minimal Ventilatory Support, Facility Use

RESPIRONICS, INC.

The following data is part of a premarket notification filed by Respironics, Inc. with the FDA for Bipap A 40 Ventilatory Support System.

Pre-market Notification Details

• Device ID: K121623
• 510k Number: K121623
• Device Name: BIPAP A 40 VENTILATORY SUPPORT SYSTEM
• Classification: Ventilator, Continuous, Minimal Ventilatory Support, Facility Use
• Applicant: RESPIRONICS, INC. 1740 GOLDEN MILE HIGHWAY Monroeville, PA 15146
• Contact: Elaine Larkin
• Correspondent: Elaine Larkin; RESPIRONICS, INC. 1740 GOLDEN MILE HIGHWAY Monroeville, PA 15146
• Product Code: MNT
• CFR Regulation Number: 868.5895 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Abbreviated
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 2012-06-01
• Decision Date: 2012-12-14
• Summary: summary

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
00606959059269	K121623	000
00606959059382	K121623	000
00606959059375	K121623	000
00606959059368	K121623	000
00606959059320	K121623	000
00606959059290	K121623	000
00606959059177	K121623	000
00606959059160	K121623	000
00606959059153	K121623	000
00606959059146	K121623	000
00606959059139	K121623	000
00606959059122	K121623	000
00606959059092	K121623	000
00606959059405	K121623	000
00606959059412	K121623	000
00606959059252	K121623	000
00606959059245	K121623	000
00606959059238	K121623	000
00606959059221	K121623	000
00606959059214	K121623	000
00606959059184	K121623	000
00606959058941	K121623	000
00606959058934	K121623	000
00606959055278	K121623	000
00606959055261	K121623	000
00606959059436	K121623	000
00606959059429	K121623	000
00606959058927	K121623	000
00606959055377	K121623	000
00606959055247	K121623	000
00606959055049	K121623	000
00606959055025	K121623	000
00606959058552	K121623	000
00606959059207	K121623	000
00606959059191	K121623	000
00606959059115	K121623	000
00606959059108	K121623	000
00606959048737	K121623	000
00606959062061	K121623	000
00606959060524	K121623	000
00606959059474	K121623	000
00606959059450	K121623	000
00606959055056	K121623	000
00606959055063	K121623	000
00606959055230	K121623	000
00606959055223	K121623	000
00606959055209	K121623	000
00606959055186	K121623	000
00606959055179	K121623	000
00606959055162	K121623	000
00606959055148	K121623	000
00606959055131	K121623	000
00606959055124	K121623	000
00606959055100	K121623	000
00606959055094	K121623	000
00606959055087	K121623	000
00606959059443	K121623	000
00606959021990	K121623	000
00606959047242	K121623	000
00606959047235	K121623	000
00606959047228	K121623	000
00606959045378	K121623	000
00606959045361	K121623	000
00606959045309	K121623	000
00606959045187	K121623	000
00606959045170	K121623	000
00606959045163	K121623	000
00606959043121	K121623	000
00606959042902	K121623	000
00606959042896	K121623	000
00606959047945	K121623	000
00606959048355	K121623	000
00606959021549	K121623	000
00606959054813	K121623	000
00606959053380	K121623	000
00606959053366	K121623	000
00606959052284	K121623	000
00606959049987	K121623	000
00606959049468	K121623	000
00606959049444	K121623	000
00606959048775	K121623	000
00606959048386	K121623	000
00606959048379	K121623	000
00606959048362	K121623	000
00606959042889	K121623	000
00606959042834	K121623	000
00606959042797	K121623	000
00606959039506	K121623	000
00606959039490	K121623	000
00606959039483	K121623	000
00606959039476	K121623	000
00606959055834	K121623	000
00606959055810	K121623	000
00606959060302	K121623	000
00606959059344	K121623	000
00606959059337	K121623	000
00606959059313	K121623	000
00606959059306	K121623	000
00606959059283	K121623	000
00606959039513	K121623	000
00606959039520	K121623	000
00606959042780	K121623	000
00606959042773	K121623	000
00606959042766	K121623	000
00606959042759	K121623	000
00606959042742	K121623	000
00606959042735	K121623	000
00606959040458	K121623	000
00606959040380	K121623	000
00606959040373	K121623	000
00606959039551	K121623	000
00606959039544	K121623	000
00606959039537	K121623	000
00606959059276	K121623	000