K232721
- 510(k) number
- K232721
- Device name
- Lifetech Cardio Temporary Pacemaker
- Applicant
- Shenzhen Lifetech Cardio Medical Electronics Co., Ltd. CN
- Product code
- DTE — Pulse-Generator, Pacemaker, External
- Decision date
- 2024-01-07
- Date received
- 2023-09-05
- Decision
- Substantially Equivalent
- Clearance type
- Special
- Advisory committee
- Cardiovascular
PDFDownload 510(k) SummaryArchived here · 2.5 MB · U.S. public domain
Also available from FDA: K232721.pdf
Official FDA record: K232721
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.