510(k) K884343
K884343 is an FDA 510(k) premarket notification submitted by Sony Corp. of America for the device "SONY COLOR VIDEO CAMERAS AND ACCESSORIES". The FDA issued a decision of Substantially Equivalent on November 1, 1988. The device falls under product code FWB (Camera, Television, Surgical, Without Audio), a Class I device regulated under 21 CFR 878.4160. Sony Corp. of America has at least 1 other 510(k) clearance on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- November 1, 1988
- Date Received
- October 14, 1988
- 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