K924277 is an FDA 510(k) clearance for the DISPOSABLE HYPODERMIC MONOPLAR NEEDLE RECORDING. This device is classified as a Preamplifier, Ac-powered, Ophthalmic (Class II - Special Controls, product code HLT).
Submitted by Chalgren Enterprises, Inc. (Gilroy, US). The FDA issued a Cleared decision on December 7, 1994, 834 days after receiving the submission on August 25, 1992.
This device falls under the Ophthalmic FDA review panel. Regulated under 21 CFR 886.1640.
| 510(k) Number | K924277 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | August 25, 1992 |
| Decision Date | December 07, 1994 |
| Days to Decision | 834 days |
| Submission Type | Traditional |
| Review Panel | Ophthalmic (OP) |
| Summary | Statement |
| Product Code | HLT — Preamplifier, Ac-powered, Ophthalmic |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 886.1640 |