ROTA SYSTEM 5000
FDA 510(k) clearance K935952 · decided 1994-04-19
Clearance details
- K-number
- K935952
- Device name
- ROTA SYSTEM 5000
- Applicant
- Rota Systems Medfurniture, Inc.
- Decision
- Substantially Equivalent
- Date received
- 1993-12-13
- Decision date
- 1994-04-19
- Days to decision
- 127 days
- Clearance type
- Traditional
- Product code
- HMF
- Device class
- 1
- Regulation number
- 886.1860
- Medical specialty
- Ophthalmic
- Advisory committee
- Ophthalmic
- Location
- Derby, KS, US
- Third-party review
- No
- Expedited review
- No
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Similar devices under this product code
Devices cleared under the same product code - the starting set for predicate research.
| Record | Firm | Date |
|---|---|---|
| ROTA DATAMATE I (K935945) | Rota Systems,Inc. | 1994-04-19 |
| ROTA SYSTEM XL (K931839) | Rota Systems Medfurniture, Inc. | 1993-11-22 |
| MARCO INTERNATIONAL STAND (K930440) | Marco Ophthalmic, Inc. | 1993-07-06 |
| BURTON OPHTHALMIC STAND - MODEL XL3200 (K924771) | R.H. Burton Co. | 1993-04-05 |
| BURTON OPHTHALMIC EXAM UNIT - MODEL 2201 (K924780) | R.H. Burton Co. | 1993-04-05 |
| OPHTHALMIC STAND (K913961) | Luneau Ophtalmologie SA | 1991-12-04 |
| RELIANCE PENDULUM OPHTHALMIC DELIVERY SYSTEM (K853358) | Dentsply Intl. | 1985-10-04 |
| OPHTHALMIC CHAIR (K844362) | Luneau Laboratories | 1984-12-11 |
| OPHTHALMIC STAND (K844363) | Luneau Laboratories | 1984-12-05 |
| ELECTRIC INSTRUMENT TABLE (K832073) | CooperVision, Inc. | 1983-08-12 |
| RELIANCE OPHTHALMIC INSTRUMENT CONTROL (K812544) | F. & F. Koenigkramer | 1981-09-21 |
| SYSTEM 1 INSTRUMENT STAND (K803195) | Surgical Mechanical Research, Inc. | 1981-02-04 |
Recalls involving this device
No recalls on record reference this clearance.