EZLink-R
EZLink-R (103201) 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 00856298006428), active as of 31 May 2026.
Active
510(k)
Valid until
No expiry
FDA recalls
None found
Documents
Trust
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | GUDID listing | Number00856298006428 | Date23 May 2024 | StatusListed |
| United States | FDA 510(k)SESE | NumberK020213 | Date5 Apr 2002 | StatusActive |
Official records
- AccessGUDID record 00856298006428
- FDA 510(k) database K020213
Across registries
- FDA 510(k) K020213 decided 5 Apr 2002 Active
- FDA GUDID UDI-DI 00856298006428 listed 23 May 2024 Listed
Timeline
- Cleared FDA 510(k) K020213
- Listed FDA GUDID 00856298006428
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- Generic name
- Cardiology information system application software
- Model / Ref / Catalog
- EZLink-R, 103201
- Primary DI / UDI-DI
- 00856298006428
- 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
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