K923877 is an FDA 510(k) clearance for the TONOSHIELD TONOMETER SHIELD. This device is classified as a Tonometer, Manual (Class II - Special Controls, product code HKY).
Submitted by Oasis Medical, Inc. (Glendora, US). The FDA issued a Cleared decision on September 30, 1992, 58 days after receiving the submission on August 3, 1992.
This device falls under the Ophthalmic FDA review panel. Regulated under 21 CFR 886.1930.
| 510(k) Number | K923877 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | August 03, 1992 |
| Decision Date | September 30, 1992 |
| Days to Decision | 58 days |
| Submission Type | Traditional |
| Review Panel | Ophthalmic (OP) |
| Summary | Statement |
| Product Code | HKY - Tonometer, Manual |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 886.1930 |