K030433 is an FDA 510(k) clearance for the STRATUSOCT WITH RNFL NORMATIVE DATABASE. This device is classified as a Ophthalmoscope, Ac-powered (Class II - Special Controls, product code HLI).
Submitted by Carl Zeiss Meditec, Inc. (Dublin, US). The FDA issued a Cleared decision on May 1, 2003, 80 days after receiving the submission on February 10, 2003.
This device falls under the Ophthalmic FDA review panel. Regulated under 21 CFR 886.1570.
| 510(k) Number | K030433 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | February 10, 2003 |
| Decision Date | May 01, 2003 |
| Days to Decision | 80 days |
| Submission Type | Traditional |
| Review Panel | Ophthalmic (OP) |
| Summary | Summary PDF |
| Product Code | HLI — Ophthalmoscope, Ac-powered |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 886.1570 |