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FDA 510(k)

Lifetech Cardio Model 8301 Temporary Pacemaker

K-Number: K182839 · 2019-02-28

ApplicantShenzhen Lifetech Cardio Medical Electronics Co., Ltd.
Decision Date2019-02-28
Product CodeDTE
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

Lifetech Cardio Model 8301 Temporary Pacemaker is a medical device manufactured by Shenzhen Lifetech Cardio Medical Electronics Co., Ltd.. It received FDA 510(k) clearance on 2019-02-28 under approval number K182839. The device is classified under product code DTE. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Lifetech Cardio Model 8301 Temporary Pacemaker?

Lifetech Cardio Model 8301 Temporary Pacemaker is a medical device that received FDA 510(k) clearance on 2019-02-28. It is manufactured by Shenzhen Lifetech Cardio Medical Electronics Co., Ltd.. The 510(k) number is K182839.

When was Lifetech Cardio Model 8301 Temporary Pacemaker approved by the FDA?

Lifetech Cardio Model 8301 Temporary Pacemaker received FDA 510(k) clearance on 2019-02-28, under approval number K182839.

What company makes Lifetech Cardio Model 8301 Temporary Pacemaker?

Lifetech Cardio Model 8301 Temporary Pacemaker is manufactured by Shenzhen Lifetech Cardio Medical Electronics Co., Ltd..

What is the FDA product code for Lifetech Cardio Model 8301 Temporary Pacemaker?

The FDA product code for Lifetech Cardio Model 8301 Temporary Pacemaker is DTE.

Related Clinical Trials

NCT03836482 Feasibility of the SCD in Cardiorenal Syndrome Patients Awaiting LVAD RECRUITING

Other Devices by Shenzhen Lifetech Cardio Medical Electronics Co., Ltd.

K232721Lifetech Cardio Temporary Pacemaker

Related Devices (Code: DTE)

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Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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