The following data is part of a premarket notification filed by Orbtek, Inc. with the FDA for Orbshot Keratometer.
| Device ID | K964891 |
| 510k Number | K964891 |
| Device Name: | ORBSHOT KERATOMETER |
| Classification | Topographer, Corneal, Ac-powered |
| Applicant | ORBTEK, INC. 3030 SOUTH MAIN ST. SUITE 600 Salt Lake City, UT 84115 |
| Contact | Pier Calacino |
| Correspondent | Pier Calacino ORBTEK, INC. 3030 SOUTH MAIN ST. SUITE 600 Salt Lake City, UT 84115 |
| Product Code | MMQ |
| CFR Regulation Number | 886.1350 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1996-12-06 |
| Decision Date | 1997-03-26 |