The following data is part of a premarket notification filed by Shenzhen Lifetech Cardio Medical Electronics Co., Ltd. with the FDA for Lifetech Cardio Model 8301 Temporary Pacemaker.
| Device ID | K182839 |
| 510k Number | K182839 |
| Device Name: | Lifetech Cardio Model 8301 Temporary Pacemaker |
| Classification | Pulse-generator, Pacemaker, External |
| Applicant | Shenzhen Lifetech Cardio Medical Electronics Co., Ltd. Rm 201, Bldg No.2, Huahan Sci-tech Industrial Park, No.16 Jinniu West Rd Shenzhen, CN 518000 |
| Contact | Stephy Pan |
| Correspondent | Stephy Pan Shenzhen Lifetech Cardio Medical Electronics Co., Ltd. Rm 201, Bldg No.2, Huahan Sci-tech Industrial Park, No.16 Jinniu West Rd Shenzhen, CN 518000 |
| Product Code | DTE |
| CFR Regulation Number | 870.3600 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2018-10-09 |
| Decision Date | 2019-02-28 |
| Summary: | summary |