The following data is part of a premarket notification filed by Chiron Vision Corp. with the FDA for Micron-scope Ii.
| Device ID | K926412 |
| 510k Number | K926412 |
| Device Name: | MICRON-SCOPE II |
| Classification | Drum, Eye Knife Test |
| Applicant | CHIRON VISION CORP. 9342 JERONIMO RD. Irvine, CA 92618 -1903 |
| Contact | Carol L Patterson |
| Correspondent | Carol L Patterson CHIRON VISION CORP. 9342 JERONIMO RD. Irvine, CA 92618 -1903 |
| Product Code | HMS |
| CFR Regulation Number | 886.4230 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1992-12-21 |
| Decision Date | 1994-07-19 |