K014044 is an FDA 510(k) clearance for the MASCULAR COMPUTERIZED PSYCHOPHYSICAL TEST (MCPT). This device is classified as a Grid, Amsler (Class I - General Controls, product code HOQ).
Submitted by Notal Vision, Inc. (Rockville, US). The FDA issued a Cleared decision on March 4, 2002, 87 days after receiving the submission on December 7, 2001.
This device falls under the Ophthalmic FDA review panel. Regulated under 21 CFR 886.1330.
| 510(k) Number | K014044 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | December 07, 2001 |
| Decision Date | March 04, 2002 |
| Days to Decision | 87 days |
| Submission Type | Traditional |
| Review Panel | Ophthalmic (OP) |
| Summary | Summary PDF |
| Product Code | HOQ - Grid, Amsler |
| Device Class | Class I - General Controls |
| CFR Regulation | 21 CFR 886.1330 |