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Epicardia 5000

by Medicomp, Inc.

Epicardia 5000 is a Class II device made by Medicomp, Inc., cleared under FDA 510(k) K090834 on 15 May 2009 and listed in FDA GUDID since 25 Sep 2023 (UDI-DI 00862887000302), active as of 8 Jun 2026.

Active United States. Also listed in GUDID (US).

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None found

in data synced 8 Jun 2026

Documents

510(k) K090834

FDA submission, from GUDID

Trust

Unverified

Source GUDID, synced 8 Jun 2026.

Regulatory status

as of registry sync 8 Jun 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing Number00862887000302 UDI-DI Date25 Sep 2023ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE from GUDID Substantially Equivalent · Special NumberK090834 Date15 May 2009DecidedStatusActive

Official records

Across registries

2 registries list this device

  • FDA 510(k) K090834 decided 15 May 2009 Active
  • FDA GUDID UDI-DI 00862887000302 listed 25 Sep 2023 Listed

Timeline

2 dated events

  1. Cleared FDA 510(k) K090834
  2. Listed FDA GUDID 00862887000302

Coverage

1 jurisdiction

United States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

United States — FDA 510(k) Active

Specification

GUDID

Generic name
Cardiology information system application software
Primary DI / UDI-DI
00862887000302
510(k) Number
FDA product code
DSI
GMDN term
Cardiology information system application software
Device class
Class II
Regulation number
870.1025
GUDID distribution status
In Commercial Distribution

Related devices

Category: Cardiology information system application software

Similar devices

Other devices filed under FDA product code DSI (Detector And Alarm, Arrhythmia).

Other devices from Medicomp, Inc.

See all devices from Medicomp, Inc. →

Properties

  • Lot / batch number
Other properties (14, all answered No)