510(k) K832342
K832342 is an FDA 510(k) premarket notification submitted by Kamiya Tsusan Kaisha, Ltd. for the device "ENDOSCOPIC CAMERA TV W/AUDIO". The FDA issued a decision of Substantially Equivalent on September 12, 1983. The device falls under product code KQM (Camera, Surgical And Accessories), a Class I device regulated under 21 CFR 878.4160. Kamiya Tsusan Kaisha, Ltd. has at least 3 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- September 12, 1983
- Date Received
- July 12, 1983
- 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