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510(k) K863643

EPICARDIA, PC/FD by Medicomp, Inc. — Product Code DSI

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 5, 1986
Date Received
September 18, 1986
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 by Medicomp, Inc.

  • K173170 — Epicardia Anywhere (January 10, 2018)
  • K161916 — TelePatch Cardiac Monitor (December 21, 2016)
  • K091696 — SAVI WIRELESS, MODEL PM500 (October 26, 2009)
  • K090834 — EPICARDIA 5000 (May 15, 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)

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  • K192732 — BodyGuardian Remote Monitoring System (March 26, 2020)
  • K190574 — Patient Assistant Model PA97000 (September 24, 2019)
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  • K181658 — MobileECG 2 BT (March 26, 2019)