The following data is part of a premarket notification filed by Carl Zeiss Meditec Inc with the FDA for Stratusoct With Rnfl Normative Database.
| Device ID | K030433 |
| 510k Number | K030433 |
| Device Name: | STRATUSOCT WITH RNFL NORMATIVE DATABASE |
| Classification | Ophthalmoscope, Ac-powered |
| Applicant | CARL ZEISS MEDITEC INC 5160 HACIENDA DR. Dublin, CA 94568 |
| Contact | R. Michael Crompton |
| Correspondent | R. Michael Crompton CARL ZEISS MEDITEC INC 5160 HACIENDA DR. Dublin, CA 94568 |
| Product Code | HLI |
| CFR Regulation Number | 886.1570 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2003-02-10 |
| Decision Date | 2003-05-01 |
| Summary: | summary |