510(k) K925276
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- May 24, 1993
- Date Received
- October 20, 1992
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Endoscope, Battery-Powered And Accessories
- Device Class
- Class II
- Regulation Number
- 876.1500
- Review Panel
- GU
- Submission Type