Submission Details
| 510(k) Number | K232721 FDA.gov |
| FDA Decision | Cleared SESE |
| Date Received | September 05, 2023 |
| Decision Date | January 07, 2024 |
| Days to Decision | 124 days |
| Submission Type | Special |
| Review Panel | Cardiovascular (CV) |
| Summary | Summary PDF |
Cleared
Special
Lifetech Cardio Temporary Pacemaker
Jan 2024
Decision
124d
Days
Class 2
Risk
About This 510(k) Submission
K232721 is an FDA 510(k) clearance for the Lifetech Cardio Temporary Pacemaker, 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 January 7, 2024, 124 days after receiving the submission on September 5, 2023. This device falls under the Cardiovascular review panel. Regulated under 21 CFR 870.3600.
Device Classification
| Product Code | DTE — Pulse-generator, Pacemaker, External |
| Device Class | Class II — Special Controls |
| CFR Regulation | 21 CFR 870.3600 |
Manufacturer
Shenzhen Lifetech Cardio Medical Electronics Co., Ltd.
Shenzhen · CN
Stephy Pan
2 submissions
2 cleared
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