510(k) K931839
- Device
- ROTA SYSTEM XL
- Applicant
- ROTA SYSTEMS MEDFURNITURE, INC.
- 510(k) number
- K931839
- Product code
- HMF
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 1993-11-22
- Date received
- 1993-04-13
- Regulation
- 886.1860
- Classification name
- Stand, Instrument, Ac-powered, Ophthalmic
- Medical specialty
- Ophthalmic
- Review panel
- Ophthalmic
- Device class
- 1
- Clearance type
- Traditional
- Statement or summary
- Statement
- Third party reviewed
- No
Applicant Contact#
- Contact
- SAM R MYERS
- Address
- 519 N. Buckner P.O. Box 361 Derby KS US 67037 67037
FDA Registration Numbers#
- 3004441848
- 3013557562
- 3011689956
- 3030447506
- 3027718329
- 3003851947
- 3010673832
- 3011706110
- 3004095901
- 3010755771
- 2031508
- 3013298431
- 2242863
- 1316463
- 3014579161
- 3005405896
- 3011898560
- 3006105501
- 3003951061
- 1054713
- 3010419931
- 3005785090
- 2028159
- 3007343325
- 3014273520
- 3006087789
- 3006766059
- 3010208880
- 3010726802
- 1223498
- 9710128
- 8020986
- 9710516
- 1000379039
- 3010227033
- 3013436538
- 9617474
- 3015972897
- 3004784203
- 3027499529
- 2031962
Source Documents#
510(k) summary PDF not indicated by FDA
Other 510(k) Records For Product Code HMF #
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K935945 | ROTA DATAMATE I | Rota Systems,Inc. | 1994-04-19 |
| K935952 | ROTA SYSTEM 5000 | Rota Systems Medfurniture, Inc. | 1994-04-19 |
| K930440 | MARCO INTERNATIONAL STAND | Marco Ophthalmic, Inc. | 1993-07-06 |
| K924771 | BURTON OPHTHALMIC STAND - MODEL XL3200 | R.H. Burton Co. | 1993-04-05 |
| K924780 | BURTON OPHTHALMIC EXAM UNIT - MODEL 2201 | R.H. Burton Co. | 1993-04-05 |
| K913961 | OPHTHALMIC STAND | Luneau Ophtalmologie SA | 1991-12-04 |
| K853358 | RELIANCE PENDULUM OPHTHALMIC DELIVERY SYSTEM | Dentsply Intl. | 1985-10-04 |
| K844362 | OPHTHALMIC CHAIR | Luneau Laboratories | 1984-12-11 |
| K844363 | OPHTHALMIC STAND | Luneau Laboratories | 1984-12-05 |
| K832073 | ELECTRIC INSTRUMENT TABLE | CooperVision, Inc. | 1983-08-12 |
| K812544 | RELIANCE OPHTHALMIC INSTRUMENT CONTROL | F. & F. Koenigkramer | 1981-09-21 |
| K803195 | SYSTEM 1 INSTRUMENT STAND | Surgical Mechanical Research, Inc. | 1981-02-04 |
| K791104 | B & L OPHTHALMIC INSTRUMENT STAND | Bausch & Lomb, Inc. | 1979-07-24 |
| K791105 | B & L OPHTHALMIC CHAIR | Bausch & Lomb, Inc. | 1979-07-24 |
Legacy Summary#
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FDA Review#
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