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EZLink-C

by Scottcare Corporation, the

EZLink-C (103200) is a Class II device made by Scottcare Corporation, the, cleared under FDA 510(k) K020213 on 5 Apr 2002 and listed in FDA GUDID since 23 May 2024 (UDI-DI 00856298006435), active as of 21 Oct 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 21 Oct 2026

Documents

510(k) K020213

FDA submission, from GUDID

Trust

Unverified

Source GUDID, synced 21 Oct 2026.

Regulatory status

as of registry sync 21 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing Number00856298006435 UDI-DI Date23 May 2024ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE from GUDID Substantially Equivalent · Traditional NumberK020213 Date5 Apr 2002DecidedStatusActive

Official records

Across registries

2 registries list this device

  • FDA 510(k) K020213 decided 5 Apr 2002 Active
  • FDA GUDID UDI-DI 00856298006435 listed 23 May 2024 Listed

Timeline

2 dated events

  1. Cleared FDA 510(k) K020213
  2. Listed FDA GUDID 00856298006435

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  • Withdrawn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
Model / Ref / Catalog
EZLink-C, 103200
Primary DI / UDI-DI
00856298006435
510(k) Number
FDA product code
DXH
GMDN term
Cardiology information system application software
Device class
Class II
Regulation number
870.2920
GUDID distribution status
In Commercial Distribution

Related devices

Category: Cardiology information system application software

Cleared under the same submission (K020213)

Similar devices

Other devices filed under FDA product code DXH (Transmitters And Receivers, Electrocardiograph, Telephone).

Other devices from Scottcare Corporation, the

See all devices from Scottcare Corporation, the →

Properties

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