510(k) K931876
K931876 is an FDA 510(k) premarket notification submitted by Vvortex International Corp. for the device "FISK ARM SUPPORT". The FDA issued a decision of Substantially Equivalent on September 9, 1993. The device falls under product code FWW (Table, Operating-Room, Pneumatic), a Class I device regulated under 21 CFR 878.4960.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- September 9, 1993
- Date Received
- April 14, 1993
- 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