The following data is part of a premarket notification filed by Carl Zeiss Meditec Inc with the FDA for Gdxpro.
| Device ID | K093521 |
| 510k Number | K093521 |
| Device Name: | GDXPRO |
| Classification | Ophthalmoscope, Laser, Scanning |
| Applicant | CARL ZEISS MEDITEC INC 5160 HACIENDA DR. Dublin, CA 94551 |
| Contact | Judy A Brimacombe |
| Product Code | MYC |
| CFR Regulation Number | 886.1570 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | Yes |
| Combination Product | No |
| Date Received | 2009-11-13 |
| Decision Date | 2009-11-25 |
| Summary: | summary |