Product code BYT— Anesthesiology
CAM-10 CHEST SHELL
- Classification name
- Ventilator, External Body, Negative Pressure, Adult (Cuirass)
- Device class
- Class 2
- Regulation
- 21 CFR 868.5935
- Advisory panel
- Anesthesiology
- Total cleared
- 21
- First cleared
- Most recent
Market context for product code BYT
FDA has cleared devices under product code BYT between 1979 and 2008, filed by 15 applicant companies. No FDA device recalls reference this product code. Class II devices are moderate-risk and subject to general and special controls; most reach market through 510(k) clearance by demonstrating substantial equivalence to a predicate device.
Clearances per year
- 2008
- 1993
- 1991
- 1990
- 1989
- 1988
- 1986
- 1984
- 1983
- 1981
- 1980
- 1979
Top applicants under product code BYT
Recent clearances under product code BYT
- K082657 — RTX RESPIRATOR
- K072290 — PEGASO V, NEGAVENT RESPIRATOR, MODEL: DA-3 PLUS
- K924341 — HAYEK OSCILLATOR(TM)
- K910947 — NEV-10 NEGATIVE PRESSURE VENTILATOR
- K905530 — PURITAN-BENNETT COMPANION 500 LIQUID OXYGEN SYSTEM
- K902764 — EMERSON 33-AN NEGATIVE PRESSURE RESPIRATOR ALARM
- K903745 — THE HAYEK OSCILLATOR
- K902300 — EASY BREATHER MODEL 100 ACCESSORIES
- K895849 — RESPIRONICS VACUVEST RESPIRATORY SUPPORT SYSTEM
- K894649 — EMERSON 33-CR CHEST RESPIRATOR
- K893213 — EASY BREATHER MODEL 100
- K881808 — EMERSON CHEST RESPIRATOR, MODEL 33-CRE
- K881689 — LINDLEY II RESUSCITATOR
- K863300 — Q101 DIAGNOSTIC SPIROMETER
- K860692 — PTR MK II VENTILATOR
- K840885 — LAKEVILLE BODY VENTILATOR
- K841090 — VENTILATOR EXTERNAL BODY NEGATIVE PRESS
- K832176 — NEGATIVE PRESSURE CHEST RESPIRATOR PUMP
- K813326 — TROCKI BODY VENTRILATOR
- K792673 — CAM-10 CUIRASS SHELL
- K791406 — CAM-10 CHEST SHELL
Data sourced from openFDA. This site is unofficial and independent of the FDA.