The following data is part of a premarket notification filed by Ellex Medical Pty Ltd. with the FDA for Eye Prime.
| Device ID | K190786 |
| 510k Number | K190786 |
| Device Name: | Eye Prime |
| Classification | System, Imaging, Pulsed Echo, Ultrasonic |
| Applicant | Ellex Medical Pty Ltd. 3-4 Second Avenue Mawson Lakes Mawson Lakes, AU 5095 |
| Contact | Andrew Pfeiffer |
| Correspondent | Mark Job REGULATORY TECHNOLOGY SERVICES, LLC 1394 25TH STREET, NW Buffalo, MN 55313 |
| Product Code | IYO |
| CFR Regulation Number | 892.1560 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | Yes |
| Combination Product | No |
| Date Received | 2019-03-27 |
| Decision Date | 2019-04-11 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 09342395000373 | K190786 | 000 |