EHC 400 DESKTOP PATIENT STATION, EHC 600 CORE PROVIDER STATION— 510(k) K000237

Substantially Equivalent

Cybercare, Inc.

FDA 510(k) clearance K000237 for EHC 400 DESKTOP PATIENT STATION, EHC 600 CORE PROVIDER STATION, Substantially Equivalent on 2000-06-13. Applicant: Cybercare, Inc..

Clearance details

Applicant: Cybercare, Inc.
Product code: Code DXN
Advisory panel: Cardiovascular
Date received: 2000-01-27
Decision date: 2000-06-13
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Atlanta, GA, US

Download summary PDF View on FDA.gov ↗

Adverse events under product code DXN

product code DXN

Death: 3
Injury: 169
Malfunction: 1,019
Other: 2
Total: 1,193

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

Data sourced from openFDA. This site is unofficial and independent of the FDA.