K813123 is an FDA 510(k) clearance for the EPC FILTER. This device is classified as a Amplifier And Signal Conditioner, Biopotential (Class II - Special Controls, product code DRR).
Submitted by Codman & Shurtleff, Inc. (Mchenry, US). The FDA issued a Cleared decision on November 27, 1981, 23 days after receiving the submission on November 4, 1981.
This device falls under the Cardiovascular FDA review panel. Regulated under 21 CFR 870.2050.
| 510(k) Number | K813123 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | November 04, 1981 |
| Decision Date | November 27, 1981 |
| Days to Decision | 23 days |
| Submission Type | Traditional |
| Review Panel | Cardiovascular (CV) |
| Summary | - |
| Product Code | DRR - Amplifier And Signal Conditioner, Biopotential |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 870.2050 |