The following data is part of a premarket notification filed by Carl Zeiss Meditec Inc. with the FDA for Gdx Vcc With Ecc Software.
| Device ID | K082016 |
| 510k Number | K082016 |
| Device Name: | GDX VCC WITH ECC SOFTWARE |
| Classification | Ophthalmoscope, Laser, Scanning |
| Applicant | CARL ZEISS MEDITEC INC. 5160 HACIENDA DRIVE Dublin, CA 94568 |
| Contact | Judith A Brimacombe |
| Correspondent | Judith A Brimacombe CARL ZEISS MEDITEC INC. 5160 HACIENDA DRIVE Dublin, CA 94568 |
| Product Code | MYC |
| CFR Regulation Number | 886.1570 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2008-07-15 |
| Decision Date | 2009-08-10 |
| Summary: | summary |