510(k) K841116
K841116 is an FDA 510(k) premarket notification submitted by Surgi-Quip Inc.U for the device "MOBILE OPHTHALMIC OPERATING TABLE". The FDA issued a decision of Substantially Equivalent on May 9, 1984. The device falls under product code FWX (Table, Operating-Room, Mechanical), a Class I device regulated under 21 CFR 878.4950. Surgi-Quip Inc.U has at least 7 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- May 9, 1984
- Date Received
- March 15, 1984
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Table, Operating-Room, Mechanical
- Device Class
- Class I
- Regulation Number
- 878.4950
- Review Panel
- SU
- Submission Type