K182839 is an FDA 510(k) clearance for the Lifetech Cardio Model 8301 Temporary Pacemaker. This device is classified as a Pulse-generator, Pacemaker, External (Class II - Special Controls, product code DTE).
Submitted by Shenzhen Lifetech Cardio Medical Electronics Co., Ltd. (Shenzhen, CN). The FDA issued a Cleared decision on February 28, 2019, 142 days after receiving the submission on October 9, 2018.
This device falls under the Cardiovascular FDA review panel. Regulated under 21 CFR 870.3600.
| 510(k) Number | K182839 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | October 09, 2018 |
| Decision Date | February 28, 2019 |
| Days to Decision | 142 days |
| Submission Type | Traditional |
| Review Panel | Cardiovascular (CV) |
| Summary | Summary PDF |
| Product Code | DTE - Pulse-generator, Pacemaker, External |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 870.3600 |