510(k) K863161
K863161 is an FDA 510(k) premarket notification submitted by Kamiya Tsusan Kaisha, Ltd. for the device "TABLE, OPERATING ROOM, HYDRAULIC". The FDA issued a decision of Substantially Equivalent on September 5, 1986. The device falls under product code FWW (Table, Operating-Room, Pneumatic), a Class I device regulated under 21 CFR 878.4960. Kamiya Tsusan Kaisha, Ltd. has at least 3 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- September 5, 1986
- Date Received
- August 18, 1986
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Table, Operating-Room, Pneumatic
- Device Class
- Class I
- Regulation Number
- 878.4960
- Review Panel
- SU
- Submission Type