Cleared Traditional

Lifetech Cardio Model 8301 Temporary Pacemaker

K182839 · Shenzhen Lifetech Cardio Medical Electronics Co., Ltd. · Cardiovascular

Feb 2019

Decision

142d

Days

Class 2

Risk

About This 510(k) Submission

K182839 is an FDA 510(k) clearance for the Lifetech Cardio Model 8301 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 February 28, 2019, 142 days after receiving the submission on October 9, 2018. This device falls under the Cardiovascular review panel. Regulated under 21 CFR 870.3600.

Submission Details

510(k) Number	K182839 FDA.gov
FDA Decision	Cleared SESE
Date Received	October 09, 2018
Decision Date	February 28, 2019
Days to Decision	142 days
Submission Type	Traditional
Review Panel	Cardiovascular (CV)
Summary	Summary PDF