Home / 510(k) Clearances / K182532

510(k) K182532

Liba3 System by National Cardiac, Inc. — Product Code DSI

K182532 is an FDA 510(k) premarket notification submitted by National Cardiac, Inc. for the device "Liba3 System". The FDA issued a decision of Substantially Equivalent on May 15, 2019. 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
May 15, 2019
Date Received
September 14, 2018
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)
  • K192732 — BodyGuardian Remote Monitoring System (March 26, 2020)
  • K190574 — Patient Assistant Model PA97000 (September 24, 2019)
  • K181658 — MobileECG 2 BT (March 26, 2019)
  • K173969 — Medicalgorithmics Unified Cardiac Rehabilitation System (July 11, 2018)

FDA data resources