RetCam Envision
Camera, Ophthalmic, Ac-powered
Natus Medical Incorporated DBA Excel-Tech Ltd. (Xltek)
The following data is part of a premarket notification filed by Natus Medical Incorporated Dba Excel-tech Ltd. (xltek) with the FDA for Retcam Envision.
Pre-market Notification Details
| Device ID | K203500 |
| 510k Number | K203500 |
| Device Name: | RetCam Envision |
| Classification | Camera, Ophthalmic, Ac-powered |
| Applicant | Natus Medical Incorporated DBA Excel-Tech Ltd. (Xltek) 2568 Bristol Circle Oakville, CA L6h 5s1 |
| Contact | Sanjay Mehta |
| Correspondent | Sanjay Mehta Natus Medical Incorporated DBA Excel-Tech Ltd. (Xltek) 2568 Bristol Circle Oakville, CA L6h 5s1 |
| Product Code | HKI |
| CFR Regulation Number | 886.1120 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2020-11-30 |
| Decision Date | 2021-04-13 |
| Summary: | summary |
NIH GUDID Devices
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00382830060110 | K203500 | 000 |
| 00382830058681 | K203500 | 000 |
| 00382830058674 | K203500 | 000 |
| 00382830056335 | K203500 | 000 |
| 00382830016896 | K203500 | 000 |
Trademark Results [RetCam Envision]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 RETCAM ENVISION 88065534 not registered Live/Pending |
Natus Medical Incorporated 2018-08-04 |
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