Lamp, Operating-Room
FDA product code FQP · Class II (moderate risk) · 21 CFR 878.4580 · General, Plastic Surgery
5510(k) clearances
0PMA approvals
0recalls
Manufacturers
510(k) clearances
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K001223 | Aculux, Model AX3001, AX3002FQP · Traditional | Aculux | 06/23/2000SE |
| K993314 | Synthes Light GuideFQP · Abbreviated | Synthes (Usa) | 12/06/1999SE |
| K781581 | Surgical Light 22 SeriesFQP · Traditional | American Sterilizer Co. | 10/17/1978SE |
| K770812 | Handles, Light, Surgical, SteoileFQP · Traditional | Sybron Corp. | 05/23/1977SE |
| K761018 | Surgical Light - Challenge 22 SeriesFQP · Traditional | Amsco Co. | 01/26/1977SE |