B & L Ophthalmic Instrument Stand
FDA 510(k) K791104 · Bausch & Lomb, Inc.
510(k) numberK791104
Submission
- Device name
- B & L Ophthalmic Instrument Stand
- Applicant
- Bausch & Lomb, Inc.
Mchenry, IL, US - Received
- June 13, 1979
- Decision date
- July 24, 1979
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Device classification
- Product code
- HMF – Stand, Instrument, Ac-Powered, Ophthalmic
- Device class
- Class I (low risk)
- Regulation
- 21 CFR 886.1860
- Specialty
- Ophthalmic
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| 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 |
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Questions and answers
When was B & L Ophthalmic Instrument Stand cleared by the FDA?
B & L Ophthalmic Instrument Stand (K791104) received a 510(k) decision of Substantially Equivalent on July 24, 1979, 41 days after the submission was received.
What is the product code of K791104?
The FDA product code is HMF – Stand, Instrument, Ac-Powered, Ophthalmic, a Class I (low risk) device regulated under 21 CFR 886.1860.