← FDA Medical Device Classifications
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FRA · Class II — Moderate Risk (510(k) clearance required) · General Hospital · 21 CFR 880.6500
Classification
- FDA Product Code
FRA- Device class
- Class II — Moderate Risk (510(k) clearance required)
- Regulation
- 21 CFR 880.6500
- Review panel
- HO
- Medical specialty
- General Hospital
- Submission type
- 1
- GMP exempt
- N
- Life sustaining
- N
- Implant
- N
- Third-party review
- Y
Market data
- Cleared 510(k) submissions
- 36
- Registered establishments
- 16
Source
- Authoritative
- FDA Device Classification database
- Machine
- JSON-LD · Markdown