K033123 is an FDA 510(k) clearance for the STRATUSOCT WITH RNFL & MACULA 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 April 20, 2004, 203 days after receiving the submission on September 30, 2003.
This device falls under the Radiology FDA review panel. Regulated under 21 CFR 886.1570.
| 510(k) Number | K033123 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | September 30, 2003 |
| Decision Date | April 20, 2004 |
| Days to Decision | 203 days |
| Submission Type | Abbreviated |
| Review Panel | Radiology (RA) |
| Summary | Summary PDF |
| Product Code | HLI — Ophthalmoscope, Ac-powered |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 886.1570 |