The following data is part of a premarket notification filed by Nidek, Inc. with the FDA for Nidek Km-1000 Surgical Keratometer.
| Device ID | K862137 |
| 510k Number | K862137 |
| Device Name: | NIDEK KM-1000 SURGICAL KERATOMETER |
| Classification | Keratoscope, Ac-powered |
| Applicant | NIDEK, INC. 2460 EMBARCADERO WAY P.O.BOX 50488 Palo Alto, CA 94303 |
| Contact | John Bratkowsky |
| Correspondent | John Bratkowsky NIDEK, INC. 2460 EMBARCADERO WAY P.O.BOX 50488 Palo Alto, CA 94303 |
| Product Code | HLQ |
| CFR Regulation Number | 886.1350 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1986-06-04 |
| Decision Date | 1986-07-23 |