K083674 is an FDA 510(k) clearance for the PK-141 PATIENT CABLE. This device is classified as a Analyzer, Pacemaker Generator Function (Class II - Special Controls, product code DTC).
Submitted by Biotronik, Inc. (Lake Oswego, US). The FDA issued a Cleared decision on April 1, 2009, 111 days after receiving the submission on December 11, 2008.
This device falls under the Cardiovascular FDA review panel. Regulated under 21 CFR 870.3630.
| 510(k) Number | K083674 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | December 11, 2008 |
| Decision Date | April 01, 2009 |
| Days to Decision | 111 days |
| Submission Type | Traditional |
| Review Panel | Cardiovascular (CV) |
| Summary | Summary PDF |
| Product Code | DTC — Analyzer, Pacemaker Generator Function |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 870.3630 |