510(k) K982965
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- November 23, 1998
- Date Received
- August 25, 1998
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Camera, Television, Endoscopic, Without Audio
- Device Class
- Class I
- Regulation Number
- 878.4160
- Review Panel
- SU
- Submission Type