ORBSHOT KERATOMETER
FDA 510(k) clearance K964891 · decided 1997-03-26
Clearance details
- K-number
- K964891
- Device name
- ORBSHOT KERATOMETER
- Applicant
- Orbtek, Inc.
- Decision
- Substantially Equivalent
- Date received
- 1996-12-06
- Decision date
- 1997-03-26
- Days to decision
- 110 days
- Clearance type
- Traditional
- Product code
- MMQ
- Device class
- 1
- Regulation number
- 886.1350
- Medical specialty
- Ophthalmic
- Advisory committee
- Ophthalmic
- Location
- Salt Lake City, UT, US
- Third-party review
- No
- Expedited review
- No
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Similar devices under this product code
Devices cleared under the same product code - the starting set for predicate research.
| Record | Firm | Date |
|---|---|---|
| SILON TOPOMAT CORNEAL TOPOGRAPHY IMAGE ENHANCEMENT DEVICE (K981665) | Bio-Medical Sciences, Inc. | 1998-12-07 |
| EUCLID SYSTEMS CORNEAL TOPOGRAPHER MODEL ET800 (K964702) | Euclid Systems Corp. | 1997-05-20 |
| CORNEAL TOPOGRAPHER 200 (K963762) | Eclipse Ventures | 1996-12-23 |
| INTRAOPERATIVE CORNEAL TOPOGRAPHY SYSTEM (I-CTS) (K950077) | Par Vision Systems Corp. | 1995-06-14 |
Recalls involving this device
No recalls on record reference this clearance.