The following data is part of a premarket notification filed by Kera Corp. with the FDA for Kerascan Model 2000 Keratographic Auto Analyzer.
| Device ID | K864037 |
| 510k Number | K864037 |
| Device Name: | KERASCAN MODEL 2000 KERATOGRAPHIC AUTO ANALYZER |
| Classification | Instrument, Measuring, Corneal Radius |
| Applicant | KERA CORP. 2362 WALSH AVE. Santa Clara, CA 95051 |
| Contact | William B Collins |
| Correspondent | William B Collins KERA CORP. 2362 WALSH AVE. Santa Clara, CA 95051 |
| Product Code | HJB |
| CFR Regulation Number | 886.1450 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1986-10-16 |
| Decision Date | 1986-11-13 |