Panels › Anesthesiology › Product code BYT · Class 2
Ventilator, External Body, Negative Pressure, Adult (Cuirass)
Regulation 868.5935
0510(k)s in 12 months (21 all time)
0recalls in 12 months (0 all time)
0recalls that name a 510(k)
Top companies in BYT
| Company | 510(k)s | Recalls |
|---|---|---|
| J. H. Emerson Co. | 3 | 0 |
| Lifecare Services, Inc. | 3 | 0 |
| Progressive Productions , Ltd. | 2 | 0 |
| Respironics, Inc. | 2 | 0 |
| Bear Medical Systems, Inc. | 1 | 0 |
| Dima Italia Srl | 1 | 0 |
| Edwards Ventilator Co. | 1 | 0 |
| Emerson Intl. Co. | 1 | 0 |
| Flexco Medical Instruments | 1 | 0 |
| L.T.D. 3 Co. | 1 | 0 |
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Oct 8, 2008 | K082657 | RTX RESPIRATOR Medivent Limited, GB | BYT |
| May 29, 2008 | K072290 | PEGASO V, NEGAVENT RESPIRATOR, MODEL: DA-3 PLUS Dima Italia Srl | BYT |
| Jul 21, 1993 | K924341 | HAYEK OSCILLATOR(TM) Respironics, Inc. | BYT |
| Jun 3, 1991 | K910947 | NEV-10 NEGATIVE PRESSURE VENTILATOR Lifecare Services, Inc. | BYT |
| Mar 1, 1991 | K905530 | PURITAN-BENNETT COMPANION 500 LIQUID OXYGEN SYSTEM Puritan Bennett Corp. | BYT |
| Nov 19, 1990 | K902764 | EMERSON 33-AN NEGATIVE PRESSURE RESPIRATOR ALARM J. H. Emerson Co. | BYT |
| Nov 9, 1990 | K903745 | THE HAYEK OSCILLATOR Flexco Medical Instruments, CH | BYT |
| Jul 19, 1990 | K902300 | EASY BREATHER MODEL 100 ACCESSORIES Progressive Productions , Ltd. | BYT |
| Dec 22, 1989 | K895849 | RESPIRONICS VACUVEST RESPIRATORY SUPPORT SYSTEM Respironics, Inc. | BYT |
| Oct 13, 1989 | K894649 | EMERSON 33-CR CHEST RESPIRATOR Emerson Intl. Co. | BYT |
| Aug 4, 1989 | K893213 | EASY BREATHER MODEL 100 Progressive Productions , Ltd. | BYT |
| Aug 4, 1988 | K881808 | EMERSON CHEST RESPIRATOR, MODEL 33-CRE J. H. Emerson Co. | BYT |
| Jul 8, 1988 | K881689 | LINDLEY II RESUSCITATOR Lindley Resuscitator, Inc. | BYT |
| Nov 13, 1986 | K863300 | Q101 DIAGNOSTIC SPIROMETER Quinton, Inc. | BYT |
| May 21, 1986 | K860692 | PTR MK II VENTILATOR Bear Medical Systems, Inc. | BYT |
| Jul 12, 1984 | K840885 | LAKEVILLE BODY VENTILATOR Edwards Ventilator Co. | BYT |
| May 30, 1984 | K841090 | VENTILATOR EXTERNAL BODY NEGATIVE PRESS Porta-Lung Co. | BYT |
| Sep 12, 1983 | K832176 | NEGATIVE PRESSURE CHEST RESPIRATOR PUMP J. H. Emerson Co. | BYT |
| Dec 22, 1981 | K813326 | TROCKI BODY VENTRILATOR L.T.D. 3 Co. | BYT |
| Jan 11, 1980 | K792673 | CAM-10 CUIRASS SHELL Lifecare Services, Inc. | BYT |
| Aug 10, 1979 | K791406 | CAM-10 CHEST SHELL Lifecare Services, Inc. | BYT |
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