The following data is part of a premarket notification filed by Optovue, Inc. with the FDA for Icam Fundus Camera.
| Device ID | K122572 |
| 510k Number | K122572 |
| Device Name: | ICAM FUNDUS CAMERA |
| Classification | Camera, Ophthalmic, Ac-powered |
| Applicant | OPTOVUE, INC. 2800 Bayview Dr Fremont, CA 94538 |
| Contact | Azimun Jamal |
| Correspondent | Azimun Jamal OPTOVUE, INC. 2800 Bayview Dr Fremont, CA 94538 |
| Product Code | HKI |
| CFR Regulation Number | 886.1120 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2012-08-23 |
| Decision Date | 2013-01-11 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00858848006414 | K122572 | 000 |
| 00858848006339 | K122572 | 000 |
| 00858848006322 | K122572 | 000 |
| 00858848006278 | K122572 | 000 |
| 00858848006780 | K122572 | 000 |