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510(k) K090834

EPICARDIA 5000 by Medicomp, Inc. — Product Code DSI

K090834 is an FDA 510(k) premarket notification submitted by Medicomp, Inc. for the device "EPICARDIA 5000". The FDA issued a decision of Substantially Equivalent on May 15, 2009. The device falls under product code DSI (Detector And Alarm, Arrhythmia), a Class II device regulated under 21 CFR 870.1025. Medicomp, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 15, 2009
Date Received
March 27, 2009
Clearance Type
Special
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 by Medicomp, Inc.

  • K173170 — Epicardia Anywhere (January 10, 2018)
  • K161916 — TelePatch Cardiac Monitor (December 21, 2016)
  • K091696 — SAVI WIRELESS, MODEL PM500 (October 26, 2009)
  • K043454 — CARDIOPAL AI WITH DIOGENES SV (CARDIOPAL SV), MODEL PM410 (March 24, 2005)
  • K981119 — CARDIOPAL MODEL NUMBER PM20 (October 14, 1998)
  • K952846 — EPICARDIA (September 18, 1995)
  • K943915 — HEAT AND MOISTURE EXCHANGER FILTER (HME) (October 14, 1994)
  • K900207 — EPICARDIA 4000 (July 31, 1990)
  • K883103 — EPICARDIA PC/FC (September 22, 1988)
  • K881770 — EPICARDIA LE/FD (May 31, 1988)

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)
  • K182532 — Liba3 System (May 15, 2019)
  • K181658 — MobileECG 2 BT (March 26, 2019)

FDA data resources