Reliance Ophthalmic Instrument Control
FDA 510(k) K812544 · F. & F. Koenigkramer
510(k) numberK812544
Submission
- Device name
- Reliance Ophthalmic Instrument Control
- Applicant
- F. & F. Koenigkramer
Mchenry, IL, US - Received
- September 4, 1981
- Decision date
- September 21, 1981
- 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
Other 510(k)s with product code HMF
| 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 |
More from Luneau Laboratories
| 510(k) | Device | Decision |
|---|---|---|
| K860519 | Reliance Model 200 Podiatry ChairLGX · Traditional | 02/19/1986SE |
| K853151 | Reliance 5000HME · Traditional | 09/05/1985SE |
| K853150 | Reliance 6100HME · Traditional | 09/05/1985SE |
| K853149 | Reliance 1000, Reliance 1500, Reliance 2000HME · Traditional | 09/05/1985SE |
| K843046 | Reliance Treatment CabinetETF · Traditional | 09/27/1984SE |
| K834060 | Reliance Ophthalmic Slit Lamp R-083HQF · Traditional | 02/04/1984SE |
| K831568 | Reliance Tempo Ophth. Instr StandHHF · Traditional | 06/30/1983SE |
| K761147 | Reliance Mod-U-Line M-700FPO · Traditional | 01/28/1977SE |
Questions and answers
When was Reliance Ophthalmic Instrument Control cleared by the FDA?
Reliance Ophthalmic Instrument Control (K812544) received a 510(k) decision of Substantially Equivalent on September 21, 1981, 17 days after the submission was received.
What is the product code of K812544?
The FDA product code is HMF – Stand, Instrument, Ac-Powered, Ophthalmic, a Class I (low risk) device regulated under 21 CFR 886.1860.