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 the device name listed in this FDA 510(k) record. The listed applicant is Shenzhen Lifetech Cardio Medical Electronics Co., Ltd.. It received FDA 510(k) clearance on 2019-02-28 under 510(k) 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. The listed applicant is Shenzhen Lifetech Cardio Medical Electronics Co., Ltd.. The 510(k) number is K182839.

When did Lifetech Cardio Model 8301 Temporary Pacemaker receive FDA 510(k) clearance?

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

Who is the listed applicant for Lifetech Cardio Model 8301 Temporary Pacemaker?

The FDA 510(k) record lists Shenzhen Lifetech Cardio Medical Electronics Co., Ltd. as the applicant. This does not by itself establish the device manufacturer.

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.

Other records listing Shenzhen Lifetech Cardio Medical Electronics Co., Ltd. as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K232721Lifetech Cardio Temporary Pacemaker

Related Devices (Code: DTE)

K241781Solo Pace ControlSolo Pace, Inc.K232721Lifetech Cardio Temporary PacemakerShenzhen Lifetech Cardio Medical Electronics Co., Ltd.K201011Medtronic Model 5392 External Pulse Generator (EPG)Medtronic, Inc.K190825Medtronic Model 5392 External Pulse Generator (EPG)Medtronic, Inc.K181973Medtronic Model 5392 External Pulse Generator (EPG)Medtronic, Inc.K180873Medtronic Model 53401 External Pulse Generator (EPG)Medtronic, Inc.

Official Source

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