K070534 is an FDA 510(k) clearance for the MODIFICATION TO: OCU-FILM TIP COVER. This device is classified as a Tonometer, Manual (Class II - Special Controls, product code HKY).
Submitted by Reichert, Inc. (Depew, US). The FDA issued a Cleared decision on March 27, 2007, 29 days after receiving the submission on February 26, 2007.
This device falls under the Ophthalmic FDA review panel. Regulated under 21 CFR 886.1930.
| 510(k) Number | K070534 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | February 26, 2007 |
| Decision Date | March 27, 2007 |
| Days to Decision | 29 days |
| Submission Type | Special |
| Review Panel | Ophthalmic (OP) |
| Summary | Statement |
| Product Code | HKY - Tonometer, Manual |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 886.1930 |