← FDA Medical Device Classifications
Heater, Breathing System W/Wo Controller (Not Humidifier Or Nebulizer
BZE · Class II — Moderate Risk (510(k) clearance required) · Anesthesiology · 21 CFR 868.5270
Classification
- FDA Product Code
BZE- Device class
- Class II — Moderate Risk (510(k) clearance required)
- Regulation
- 21 CFR 868.5270
- Review panel
- AN
- Medical specialty
- Anesthesiology
- Submission type
- 1
- GMP exempt
- N
- Life sustaining
- N
- Implant
- N
- Third-party review
- Y
Market data
- Cleared 510(k) submissions
- 45
- Registered establishments
- 50
Source
- Authoritative
- FDA Device Classification database
- Machine
- JSON-LD · Markdown