510(k) K001111
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- July 7, 2000
- Date Received
- April 6, 2000
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Retinoscope, Ac-Powered
- Device Class
- Class II
- Regulation Number
- 886.1780
- Review Panel
- OP
- Submission Type