510(k) K934092
K934092 is an FDA 510(k) premarket notification submitted by Envision Medical Corp. for the device "CAMERA, SURGICAL AND ACCESSORIES". The FDA issued a decision of Substantially Equivalent on January 7, 1994. The device falls under product code FWB (Camera, Television, Surgical, Without Audio), a Class I device regulated under 21 CFR 878.4160. Envision Medical Corp. has at least 4 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- January 7, 1994
- Date Received
- August 23, 1993
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Camera, Television, Surgical, Without Audio
- Device Class
- Class I
- Regulation Number
- 878.4160
- Review Panel
- SU
- Submission Type