← FDA Medical Device Classifications
Shield, Eye, Radiological
IWS · Class I — Low Risk (general controls) · Radiology · 21 CFR 892.6500
Classification
- FDA Product Code
IWS- Device class
- Class I — Low Risk (general controls)
- Regulation
- 21 CFR 892.6500
- Review panel
- RA
- Medical specialty
- Radiology
- Submission type
- 4
- GMP exempt
- N
- Life sustaining
- N
- Implant
- N
- Third-party review
- N
Market data
- Cleared 510(k) submissions
- 6
- Registered establishments
- 55
Source
- Authoritative
- FDA Device Classification database
- Machine
- JSON-LD · Markdown