Stand, Instrument, Ac-Powered, Ophthalmic
FDA product code HMF · Class I (low risk) · 21 CFR 886.1860 · Ophthalmic
15510(k) clearances
0PMA approvals
0recalls
Manufacturers
510(k) clearances
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K935952 | Rota System 5000HMF · Traditional | Rota Systems Medfurniture, Inc. | 04/19/1994SE |
| K935945 | Rota Datamate IHMF · Traditional | Rota Systems,Inc. | 04/19/1994SE |
| K931839 | Rota System XLHMF · Traditional | Rota Systems Medfurniture, Inc. | 11/22/1993SE |
| K930440 | Marco International StandHMF · Traditional | Marco Ophthalmic, Inc. | 07/06/1993SE |
| K924780 | Burton Ophthalmic Exam Unit - Model 2201HMF · Traditional | R.H. Burton Co. | 04/05/1993SE |
| K924771 | Burton Ophthalmic Stand - Model XL3200HMF · Traditional | R.H. Burton Co. | 04/05/1993SE |
| K913961 | Ophthalmic StandHMF · Traditional | Luneau Ophtalmologie SA | 12/04/1991SE |
| K853358 | Reliance Pendulum Ophthalmic Delivery SystemHMF · Traditional | Dentsply Intl. | 10/04/1985SE |
| K844362 | Ophthalmic ChairHMF · Traditional | Luneau Laboratories | 12/11/1984SE |
| K844363 | Ophthalmic StandHMF · Traditional | Luneau Laboratories | 12/05/1984SE |
| K832073 | Electric Instrument TableHMF · Traditional | CooperVision, Inc. | 08/12/1983SE |
| K812544 | Reliance Ophthalmic Instrument ControlHMF · Traditional | F. & F. Koenigkramer | 09/21/1981SE |
| K803195 | System 1 Instrument StandHMF · Traditional | Surgical Mechanical Research, Inc. | 02/04/1981SE |
| K791105 | B & L Ophthalmic ChairHMF · Traditional | Bausch & Lomb, Inc. | 07/24/1979SE |
| K791104 | B & L Ophthalmic Instrument StandHMF · Traditional | Bausch & Lomb, Inc. | 07/24/1979SE |