510(k) K885042
K885042 is an FDA 510(k) premarket notification submitted by Sony Medical Electronics Co. for the device "SONY TRINITRON COLOR VIDEO MONITOR PVM-1343MD". The FDA issued a decision of Substantially Equivalent on December 22, 1988. The device falls under product code KQM (Camera, Surgical And Accessories), a Class I device regulated under 21 CFR 878.4160. Sony Medical Electronics Co. has at least 7 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- December 22, 1988
- Date Received
- December 5, 1988
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Camera, Surgical And Accessories
- Device Class
- Class I
- Regulation Number
- 878.4160
- Review Panel
- SU
- Submission Type