K940467 is an FDA 510(k) clearance for the REMINGTON MEDICAL DISPOSABLE EXTENSION CABLE FAS-LOC FL-601. This device is classified as a Pulse-generator, Pacemaker, External (Class II - Special Controls, product code DTE).
Submitted by Remington Medical, Inc. (Atlanta, US). The FDA issued a Cleared decision on November 1, 1994, 272 days after receiving the submission on February 2, 1994.
This device falls under the Cardiovascular FDA review panel. Regulated under 21 CFR 870.3600.
| 510(k) Number | K940467 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | February 02, 1994 |
| Decision Date | November 01, 1994 |
| Days to Decision | 272 days |
| Submission Type | Traditional |
| Review Panel | Cardiovascular (CV) |
| Summary | Statement |
| Product Code | DTE - Pulse-generator, Pacemaker, External |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 870.3600 |