← FDA Medical Device Classifications
External Airway
PMB · Class II — Moderate Risk (510(k) clearance required) · Anesthesiology · 21 CFR 868.5105
Classification
- FDA Product Code
PMB- Device class
- Class II — Moderate Risk (510(k) clearance required)
- Regulation
- 21 CFR 868.5105
- Review panel
- AN
- Medical specialty
- Anesthesiology
- Submission type
- 1
- GMP exempt
- N
- Life sustaining
- N
- Implant
- N
- Third-party review
- N
Definition
This device is intended to maintain airway patency using negative pressure during mild to moderate sedation.
Market data
- Cleared 510(k) submissions
- 1
- Registered establishments
- 0
Source
- Authoritative
- FDA Device Classification database
- Machine
- JSON-LD · Markdown