Burton Ophthalmic Exam Unit - Model 2201
FDA 510(k) K924780 · R.H. Burton Co.
510(k) numberK924780
Submission
- Device name
- Burton Ophthalmic Exam Unit - Model 2201
- Applicant
- R.H. Burton Co.
Grove City, OH, US - Received
- September 23, 1992
- Decision date
- April 5, 1993
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) statement available from FDA
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 |
| 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 |
| K832073 | Electric Instrument TableHMF · Traditional | CooperVision, Inc. | 08/12/1983SE |
More from CooperVision, Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K924773 | Burton H- Base Table - Model 1990HRX · Traditional | 06/07/1993SE |
| K924786 | Burton Trial Lens SetHPC · Traditional | 04/14/1993SE |
| K924783 | Burton Slit Lamp - Model 850HJO · Traditional | 04/14/1993SE |
| K924774 | Burton Automatic Projector - Model CP-40HOD · Traditional | 04/14/1993SE |
| K924790 | Burton Auto Refractor - Model BAR-7HKO · Traditional | 04/05/1993SE |
| K924788 | Burton LensmeterHLM · Traditional | 04/05/1993SE |
| K924785 | Burton Radiusgauge - Model 2030HLM · Traditional | 04/05/1993SE |
| K924784 | Burton Projector Head - Model 6000-HHOS · Traditional | 04/05/1993SE |
| K924779 | Burton Keratometer - Modle 2040HJB · Traditional | 04/05/1993SE |
| K924778 | Burton Auto Refractor/Keratometer - Model BARK-8HKO · Traditional | 04/05/1993SE |
Questions and answers
When was Burton Ophthalmic Exam Unit - Model 2201 cleared by the FDA?
Burton Ophthalmic Exam Unit - Model 2201 (K924780) received a 510(k) decision of Substantially Equivalent on April 5, 1993, 194 days after the submission was received.
What is the product code of K924780?
The FDA product code is HMF – Stand, Instrument, Ac-Powered, Ophthalmic, a Class I (low risk) device regulated under 21 CFR 886.1860.