K093213 is an FDA 510(k) clearance for the GUIDED PROGRESSION ANALYSIS ON THE HUMPHREY FIELD ANALYZER II AND II -I SERIES. This device is classified as a Perimeter, Automatic, Ac-powered (Class I - General Controls, product code HPT).
Submitted by Carl Zeiss Meditec, Inc. (Dublin, US). The FDA issued a Cleared decision on March 12, 2010, 150 days after receiving the submission on October 13, 2009.
This device falls under the Ophthalmic FDA review panel. Regulated under 21 CFR 886.1605.
| 510(k) Number | K093213 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | October 13, 2009 |
| Decision Date | March 12, 2010 |
| Days to Decision | 150 days |
| Submission Type | Traditional |
| Review Panel | Ophthalmic (OP) |
| Summary | Summary PDF |
| Product Code | HPT — Perimeter, Automatic, Ac-powered |
| Device Class | Class I - General Controls |
| CFR Regulation | 21 CFR 886.1605 |