K132549 is an FDA 510(k) clearance for the ACCUTIP COVER. This device is classified as a Tonometer, Manual (Class II - Special Controls, product code HKY).
Submitted by Accutome, Inc. (Malvern, US). The FDA issued a Cleared decision on April 23, 2014, 252 days after receiving the submission on August 14, 2013.
This device falls under the Ophthalmic FDA review panel. Regulated under 21 CFR 886.1930.
| 510(k) Number | K132549 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | August 14, 2013 |
| Decision Date | April 23, 2014 |
| Days to Decision | 252 days |
| Submission Type | Traditional |
| Review Panel | Ophthalmic (OP) |
| Summary | Summary PDF |
| Product Code | HKY — Tonometer, Manual |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 886.1930 |