K050884 is an FDA 510(k) clearance for the ADAPTER CABLE. This device is classified as a Tester, Pacemaker Electrode Function (Class II - Special Controls, product code DTA).
Submitted by Remington Medical, Inc. (Alpharetta, US). The FDA issued a Cleared decision on May 19, 2005, 42 days after receiving the submission on April 7, 2005.
This device falls under the Cardiovascular FDA review panel. Regulated under 21 CFR 870.3720.
| 510(k) Number | K050884 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | April 07, 2005 |
| Decision Date | May 19, 2005 |
| Days to Decision | 42 days |
| Submission Type | Traditional |
| Review Panel | Cardiovascular (CV) |
| Summary | Summary PDF |
| Product Code | DTA - Tester, Pacemaker Electrode Function |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 870.3720 |