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510(k) K180873

Medtronic Model 53401 External Pulse Generator (EPG) by Medtronic, Inc. — Product Code DTE

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 19, 2018
Date Received
April 3, 2018
Clearance Type
Special
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

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Other clearances for product code DTE

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  • K181973 — Medtronic Model 5392 External Pulse Generator (EPG) (August 21, 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)