510(k) K041290
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- May 24, 2004
- Date Received
- May 13, 2004
- Clearance Type
- Special
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Ophthalmoscope, Ac-Powered
- Device Class
- Class II
- Regulation Number
- 886.1570
- Review Panel
- OP
- Submission Type