K053430 is an FDA 510(k) clearance for the TONO-PEN AVIA TONOMETER AND OCU-SHILED TIP COVER. This device is classified as a Tonometer, Manual (Class II - Special Controls, product code HKY).
Submitted by Medtronic Xomed, Inc. (Jacksonville, US). The FDA issued a Cleared decision on March 3, 2006, 84 days after receiving the submission on December 9, 2005.
This device falls under the Ophthalmic FDA review panel. Regulated under 21 CFR 886.1930.
| 510(k) Number | K053430 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | December 09, 2005 |
| Decision Date | March 03, 2006 |
| Days to Decision | 84 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 |