K921815 is an FDA 510(k) clearance for the TOMEY PE-300 PORTABLE ERG. This device is classified as a Preamplifier, Ac-powered, Ophthalmic (Class II - Special Controls, product code HLT).
Submitted by Tomey Corporation USA (Cambridge, US). The FDA issued a Cleared decision on July 15, 1992, 91 days after receiving the submission on April 15, 1992.
This device falls under the Ophthalmic FDA review panel. Regulated under 21 CFR 886.1640.
| 510(k) Number | K921815 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | April 15, 1992 |
| Decision Date | July 15, 1992 |
| Days to Decision | 91 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 |