FDA product code BYT
Ventilator, External Body, Negative Pressure, Adult (Cuirass)
Anesthesiology·Class 2·21 CFR 868.5935·Life-sustaining
US regulatory classifications
- US Product Code (FDA)
- BYTView Product Code Classification →
- US Risk Class (FDA)
- Class 2
- US Regulation (CFR)
- 21 CFR 868.5935View CFR Regulation →
- Medical specialty
- Anesthesiology
Device characteristics
- GMP exempt
- No
- Implantable
- No
- Life-sustaining
- Yes
- Third party review
- Not Eligible
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About this record
Ventilator, External Body, Negative Pressure, Adult (Cuirass) is a medical device type in the Anesthesiology specialty. This page includes real-world medical device registration data worldwide for this device type, with registrations from US FDA, Brazil ANVISA, and other global markets. This device type includes life-sustaining products.
View regulatory classifications, recent 510(k) clearances, active device registrations, and similar products registered globally under this device category. Pure Global AI's free directory provides comprehensive worldwide registration intelligence across 7,000+ medical device types and 21 specialties.