← FDA Medical Device Classifications
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INK · Class II — Moderate Risk (510(k) clearance required) · Physical Medicine · 21 CFR 890.3690
Classification
- FDA Product Code
INK- Device class
- Class II — Moderate Risk (510(k) clearance required)
- Regulation
- 21 CFR 890.3690
- Review panel
- PM
- Medical specialty
- Physical Medicine
- Submission type
- 4
- GMP exempt
- N
- Life sustaining
- N
- Implant
- N
- Third-party review
- Y
Market data
- Cleared 510(k) submissions
- 12
- Registered establishments
- 19
Source
- Authoritative
- FDA Device Classification database
- Machine
- JSON-LD · Markdown