510(k) K854988
K854988 is an FDA 510(k) premarket notification submitted by Us Jvc Corp. for the device "KY-M280U SURGICAL CAMERA". The FDA issued a decision of Substantially Equivalent on January 24, 1986. The device falls under product code FWC (Camera, Television, Surgical, With Audio), a Class I device regulated under 21 CFR 878.4160.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- January 24, 1986
- Date Received
- December 12, 1985
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Camera, Television, Surgical, With Audio
- Device Class
- Class I
- Regulation Number
- 878.4160
- Review Panel
- SU
- Submission Type