The following data is part of a premarket notification filed by Surgi-quip Inc.u with the FDA for Mobile Ophthalmic Operating Table.
| Device ID | K841116 |
| 510k Number | K841116 |
| Device Name: | MOBILE OPHTHALMIC OPERATING TABLE |
| Classification | Table, Operating-room, Mechanical |
| Applicant | SURGI-QUIP INC.U 4221 Richmond Rd., N.W. Walker, MI 49534 |
| Product Code | FWX |
| CFR Regulation Number | 878.4950 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1984-03-15 |
| Decision Date | 1984-05-09 |