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510(k) K182839

Lifetech Cardio Model 8301 Temporary Pacemaker by Shenzhen Lifetech Cardio Medical Electronics Co., Ltd. — Product Code DTE

K182839 is an FDA 510(k) premarket notification submitted by Shenzhen Lifetech Cardio Medical Electronics Co., Ltd. for the device "Lifetech Cardio Model 8301 Temporary Pacemaker". The FDA issued a decision of Substantially Equivalent on February 28, 2019. The device falls under product code DTE (Pulse-Generator, Pacemaker, External), a Class II device regulated under 21 CFR 870.3600. Shenzhen Lifetech Cardio Medical Electronics Co., Ltd. has at least 1 other 510(k) clearance on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
February 28, 2019
Date Received
October 9, 2018
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Pulse-Generator, Pacemaker, External
Device Class
Class II
Regulation Number
870.3600
Review Panel
CV
Submission Type

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

  • K232721 — Lifetech Cardio Temporary Pacemaker (January 7, 2024)

Other clearances for product code DTE

  • K241781 — Solo Pace Control (January 10, 2025)
  • K232721 — Lifetech Cardio Temporary Pacemaker (January 7, 2024)
  • K201011 — Medtronic Model 5392 External Pulse Generator (EPG) (May 13, 2020)
  • K190825 — Medtronic Model 5392 External Pulse Generator (EPG) (April 30, 2019)
  • K181973 — Medtronic Model 5392 External Pulse Generator (EPG) (August 21, 2018)
  • K180873 — Medtronic Model 53401 External Pulse Generator (EPG) (April 19, 2018)
  • K162054 — Medtronic Temporary External Pacemaker 53401 (October 18, 2016)
  • K162550 — Medtronic Model 5392 External Pulse Generator (EPG) (October 12, 2016)
  • K150246 — Medtronic Model 5392 External Pulse Generator (EPG) (February 18, 2015)
  • K132924 — MEDTRONIC EXTERNAL PULSE GENERATOR (EPG) (October 31, 2013)

FDA data resources