BYT — Ventilator, External Body, Negative Pressure, Adult (Cuirass) Class II
FDA product code BYT covers "Ventilator, External Body, Negative Pressure, Adult (Cuirass)", a Class II medical device regulated under 21 CFR 868.5935. Submissions are reviewed by the Anesthesiology panel. At least 20 recent 510(k) clearances have been granted under this product code.
Classification Details
- Product Code
- BYT
- Device Class
- Class II
- Regulation Number
- 868.5935
- Submission Type
- Review Panel
- AN
- Medical Specialty
- Anesthesiology
- Implant
- No
Recent 510(k) Clearances
| K-Number | Applicant | Device Name | Date |
|---|---|---|---|
| K082657 | medivent limited | RTX RESPIRATOR | October 8, 2008 |
| K072290 | dima italia | PEGASO V, NEGAVENT RESPIRATOR, MODEL: DA-3 PLUS | May 29, 2008 |
| K924341 | respironics | HAYEK OSCILLATOR(TM) | July 21, 1993 |
| K910947 | lifecare services | NEV-10 NEGATIVE PRESSURE VENTILATOR | June 3, 1991 |
| K905530 | puritan bennett | PURITAN-BENNETT COMPANION 500 LIQUID OXYGEN SYSTEM | March 1, 1991 |
| K902764 | j. h. emerson | EMERSON 33-AN NEGATIVE PRESSURE RESPIRATOR ALARM | November 19, 1990 |
| K903745 | flexco medical instruments | THE HAYEK OSCILLATOR | November 9, 1990 |
| K902300 | progressive productions | EASY BREATHER MODEL 100 ACCESSORIES | July 19, 1990 |
| K895849 | respironics | RESPIRONICS VACUVEST RESPIRATORY SUPPORT SYSTEM | December 22, 1989 |
| K894649 | emerson intl | EMERSON 33-CR CHEST RESPIRATOR | October 13, 1989 |
| K893213 | progressive productions | EASY BREATHER MODEL 100 | August 4, 1989 |
| K881808 | j. h. emerson | EMERSON CHEST RESPIRATOR, MODEL 33-CRE | August 4, 1988 |
| K881689 | lindley resuscitator | LINDLEY II RESUSCITATOR | July 8, 1988 |
| K863300 | quinton | Q101 DIAGNOSTIC SPIROMETER | November 13, 1986 |
| K860692 | bear medical systems | PTR MK II VENTILATOR | May 21, 1986 |
| K840885 | edwards ventilator | LAKEVILLE BODY VENTILATOR | July 12, 1984 |
| K841090 | porta-lung | VENTILATOR EXTERNAL BODY NEGATIVE PRESS | May 30, 1984 |
| K832176 | j. h. emerson | NEGATIVE PRESSURE CHEST RESPIRATOR PUMP | September 12, 1983 |
| K813326 | l.t.d. 3 | TROCKI BODY VENTRILATOR | December 22, 1981 |
| K792673 | lifecare services | CAM-10 CUIRASS SHELL | January 11, 1980 |