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510(k) K192732

BodyGuardian Remote Monitoring System by Preventice Technologies, Inc. — Product Code DSI

K192732 is an FDA 510(k) premarket notification submitted by Preventice Technologies, Inc. for the device "BodyGuardian Remote Monitoring System". The FDA issued a decision of Substantially Equivalent on March 26, 2020. The device falls under product code DSI (Detector And Alarm, Arrhythmia), a Class II device regulated under 21 CFR 870.1025.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 26, 2020
Date Received
September 27, 2019
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Detector And Alarm, Arrhythmia
Device Class
Class II
Regulation Number
870.1025
Review Panel
CV
Submission Type

Other clearances for product code DSI

  • K243349 — BodyGuardian Remote Monitoring System (BGRMS v3.0) (January 23, 2026)
  • K250356 — MoMe ARC® Wireless Ambulatory ECG Monitoring and Detection System (32000) (July 29, 2025)
  • K240177 — Zio AT® device (A100A1001) (October 30, 2024)
  • K230265 — MoMe® ARC Wireless Ambulatory ECG Monitoring and Detection System (October 6, 2023)
  • K231276 — SmartCardia 7L Platform (August 30, 2023)
  • K193104 — Unified Arrhythmia Diagnostic System PocketECG IV (April 9, 2020)
  • K190574 — Patient Assistant Model PA97000 (September 24, 2019)
  • K182532 — Liba3 System (May 15, 2019)
  • K181658 — MobileECG 2 BT (March 26, 2019)
  • K173969 — Medicalgorithmics Unified Cardiac Rehabilitation System (July 11, 2018)

FDA data resources