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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device detector and alarm, arrhythmia
Regulation Description Arrhythmia detector and alarm (including ST-segment measurement and alarm).
Product CodeDSI
Regulation Number 870.1025
Device Class 2


Premarket Reviews
ManufacturerDecision
BOSTON SCIENTIFIC CARDIAC DIAGNOSTIC TECHNOLOGIES, INC.
  SUBSTANTIALLY EQUIVALENT 1
INFOBIONIC, INC.
  SUBSTANTIALLY EQUIVALENT 2
IRHYTHM TECHNOLOGIES, INC.
  SUBSTANTIALLY EQUIVALENT 1
MEDICALGORITHMICS S.A.
  SUBSTANTIALLY EQUIVALENT 1
PREVENTICE TECHNOLOGIES, INC.
  SUBSTANTIALLY EQUIVALENT 1
SMARTCARDIA SA
  SUBSTANTIALLY EQUIVALENT 1

MDR Year MDR Reports MDR Events
2020 3084 3084
2021 622 622

Recalls
Manufacturer Recall Class Date Posted
1 GE Medical Systems Information Technologies Inc II Jun-10-2025
2 Philips North America, LLC II Jul-10-2020
3 Philips North America II Oct-08-2024
4 Philips North America II Oct-01-2024
5 Philips North America Llc II Dec-02-2025
6 Philips North America Llc II May-21-2021
7 Philips North America Llc II Dec-08-2020
8 Preventice Services, LLC II Jul-01-2020
9 Spacelabs Healthcare, Inc. II May-01-2026
10 Spacelabs Healthcare, Inc. II Apr-07-2026
11 Spacelabs Healthcare, Inc. II May-03-2023
12 iRhythm Technologies, Inc. II Nov-04-2022
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