510(k) K950077
- Device
- Intraoperative Corneal Topography System (i-cts)
- Applicant
- PAR VISION SYSTEMS CORP.
- 510(k) number
- K950077
- Product code
- MMQ
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 1995-06-14
- Date received
- 1995-01-10
- Regulation
- 886.1350
- Classification name
- Topographer, Corneal, Ac-Powered
- Medical specialty
- Ophthalmic
- Review panel
- Ophthalmic
- Device class
- 1
- Clearance type
- Traditional
- Statement or summary
- Summary
- Third party reviewed
- No
Applicant Contact#
- Contact
- JAMES L CAMBIER
- Address
- 220 Seneca Tpke. New Hartford NY US 13413 13413
FDA Registration Numbers#
- 3004441848
- 1000391004
- 3021343245
- 9611269
- 3005950902
- 3007913988
- 3033566
- 3012440389
- 9616199
- 3038356864
- 3003851947
- 3005755367
- 3003288808
- 3038287496
- 3014175039
- 3011898560
- 9615030
- 9680671
- 3014964775
- 3007177447
- 3015494167
- 3011248709
- 3043625014
- 1319721
- 3014329625
- 3013488369
- 3009578732
- 3020723591
- 3020246591
- 3010610157
- 3015972897
- 9710340
- 2521877
Source Documents#
Other 510(k) Records For Product Code MMQ#
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K981665 | SILON TOPOMAT CORNEAL TOPOGRAPHY IMAGE ENHANCEMENT DEVICE | Bio-Medical Sciences, Inc. | 1998-12-07 |
| K964702 | EUCLID SYSTEMS CORNEAL TOPOGRAPHER MODEL ET800 | Euclid Systems Corp. | 1997-05-20 |
| K964891 | ORBSHOT KERATOMETER | Orbtek, Inc. | 1997-03-26 |
| K963762 | CORNEAL TOPOGRAPHER 200 | Eclipse Ventures | 1996-12-23 |