← FDA Medical Device Classifications
Device, Antichoke, Suction
EWT · Class III — High Risk (PMA approval required, life-sustaining) · Ear, Nose, Throat · 21 CFR 874.5350
Classification
- FDA Product Code
EWT- Device class
- Class III — High Risk (PMA approval required, life-sustaining)
- Regulation
- 21 CFR 874.5350
- Review panel
- EN
- Medical specialty
- Ear, Nose, Throat
- Submission type
- 2
- GMP exempt
- N
- Life sustaining
- N
- Implant
- N
- Third-party review
- N
Definition
Call for PMAs on 7/13/99 per 64 FR 18329 on 4/14/99
Market data
- Cleared 510(k) submissions
- 0
- Registered establishments
- 0
Source
- Authoritative
- FDA Device Classification database
- Machine
- JSON-LD · Markdown