← FDA Medical Device Classifications
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IYM · Class III — High Risk (PMA approval required, life-sustaining) · Obstetrics/Gynecology · 21 CFR 884.2980
Classification
- FDA Product Code
IYM- Device class
- Class III — High Risk (PMA approval required, life-sustaining)
- Regulation
- 21 CFR 884.2980
- Review panel
- RA
- Medical specialty
- Obstetrics/Gynecology
- Submission type
- 2
- GMP exempt
- N
- Life sustaining
- N
- Implant
- N
- Third-party review
- N
Market data
- Cleared 510(k) submissions
- 8
- Registered establishments
- 0
Source
- Authoritative
- FDA Device Classification database
- Machine
- JSON-LD · Markdown