The following data is part of a premarket notification filed by Kera-metrics Corp. with the FDA for Clas Photokeratoscope.
| Device ID | K895741 |
| 510k Number | K895741 |
| Device Name: | CLAS PHOTOKERATOSCOPE |
| Classification | Keratoscope, Ac-powered |
| Applicant | KERA-METRICS CORP. 11211 SORRENTO VALLEY RD. SUITE X San Diego, CA 92121 |
| Contact | Richard T Swanson |
| Correspondent | Richard T Swanson KERA-METRICS CORP. 11211 SORRENTO VALLEY RD. SUITE X San Diego, CA 92121 |
| Product Code | HLQ |
| CFR Regulation Number | 886.1350 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1989-09-26 |
| Decision Date | 1990-07-11 |