← FDA Medical Device Classifications
Electromyograph, Diagnostic
IKN · Class II — Moderate Risk (510(k) clearance required) · Physical Medicine · 21 CFR 890.1375
Classification
- FDA Product Code
IKN- Device class
- Class II — Moderate Risk (510(k) clearance required)
- Regulation
- 21 CFR 890.1375
- Review panel
- NE
- Medical specialty
- Physical Medicine
- Submission type
- 1
- GMP exempt
- N
- Life sustaining
- N
- Implant
- N
- Third-party review
- Y
Market data
- Cleared 510(k) submissions
- 75
- Registered establishments
- 70
Source
- Authoritative
- FDA Device Classification database
- Machine
- JSON-LD · Markdown