← FDA Medical Device Classifications
Cover, Cast
KIA · Class I — Low Risk (general controls) · General Hospital · 21 CFR 880.6185
Classification
- FDA Product Code
KIA- Device class
- Class I — Low Risk (general controls)
- Regulation
- 21 CFR 880.6185
- Review panel
- HO
- Medical specialty
- General Hospital
- Submission type
- 4
- GMP exempt
- Y
- Life sustaining
- N
- Implant
- N
- Third-party review
- N
Market data
- Cleared 510(k) submissions
- 1
- Registered establishments
- 73
Source
- Authoritative
- FDA Device Classification database
- Machine
- JSON-LD · Markdown