The following data is part of a premarket notification filed by Natus Medical Incorporated with the FDA for Retcam 3 ; Retcam Shuttle ; Retcam Portable.
| Device ID | K182263 |
| 510k Number | K182263 |
| Device Name: | RetCam 3 ; RetCam Shuttle ; RetCam Portable |
| Classification | Camera, Ophthalmic, Ac-powered |
| Applicant | Natus Medical Incorporated 1183 Quarry Lane, Suite A Pleasanton, CA 94566 |
| Contact | Brian R. Ackley |
| Correspondent | Brian R. Ackley Natus Medical Incorporated 1183 Quarry Lane, Suite A Pleasanton, CA 94566 |
| Product Code | HKI |
| CFR Regulation Number | 886.1120 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2018-08-21 |
| Decision Date | 2018-09-07 |
| Summary: | summary |