The following data is part of a premarket notification filed by Clarity Medical Systems with the FDA for Ret Cam Ii, Retcam 3 And Retcam Shuttle And Portable Ophthalmic Imaging Systems.
| Device ID | K090326 |
| 510k Number | K090326 |
| Device Name: | RET CAM II, RETCAM 3 AND RETCAM SHUTTLE AND PORTABLE OPHTHALMIC IMAGING SYSTEMS |
| Classification | Camera, Ophthalmic, Ac-powered |
| Applicant | CLARITY MEDICAL SYSTEMS 5775 WEST LAS POSITAS BLVD. SUITE 200 Pleasanton, CA 94588 -4084 |
| Contact | Gary A Seeger |
| Correspondent | Gary A Seeger CLARITY MEDICAL SYSTEMS 5775 WEST LAS POSITAS BLVD. SUITE 200 Pleasanton, CA 94588 -4084 |
| Product Code | HKI |
| CFR Regulation Number | 886.1120 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2009-02-09 |
| Decision Date | 2009-11-25 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00899281002137 | K090326 | 000 |
| 00899281002120 | K090326 | 000 |