Ophthalmic Chair
FDA 510(k) K844362 · Luneau Laboratories
510(k) numberK844362
Submission
- Device name
- Ophthalmic Chair
- Applicant
- Luneau Laboratories
Washington, DC, US - Received
- November 13, 1984
- Decision date
- December 11, 1984
- 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 |
| K844363 | Ophthalmic StandHMF · Traditional | Luneau Laboratories | 12/05/1984SE |
| K832073 | Electric Instrument TableHMF · Traditional | CooperVision, Inc. | 08/12/1983SE |
More from CooperVision, Inc.
Questions and answers
When was Ophthalmic Chair cleared by the FDA?
Ophthalmic Chair (K844362) received a 510(k) decision of Substantially Equivalent on December 11, 1984, 28 days after the submission was received.
What is the product code of K844362?
The FDA product code is HMF – Stand, Instrument, Ac-Powered, Ophthalmic, a Class I (low risk) device regulated under 21 CFR 886.1860.