FDA product code BTM
Ventilator, Emergency, Manual (Resuscitator)
Anesthesiology·Class 2·21 CFR 868.5915·Life-sustaining
US regulatory classifications
- US Product Code (FDA)
- BTMView Product Code Classification →
- US Risk Class (FDA)
- Class 2
- US Regulation (CFR)
- 21 CFR 868.5915View CFR Regulation →
- Medical specialty
- Anesthesiology
Device characteristics
- GMP exempt
- No
- Implantable
- No
- Life-sustaining
- Yes
- Third party review
- Eligible
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About this record
Ventilator, Emergency, Manual (Resuscitator) 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.