EHC500 DESKTOP PATIENT STATION, MODEL EHC500— 510(k) K002388
Substantially EquivalentCybercare, Inc.
FDA 510(k) clearance K002388 for EHC500 DESKTOP PATIENT STATION, MODEL EHC500, Substantially Equivalent on 2000-08-25. Applicant: Cybercare, Inc.. Device class: 2.
Clearance details
- Applicant
- Cybercare, Inc.
- Product code
- Code DXN
- Device class
- Class 2
- Regulation
- 21 CFR 870.1130
- Advisory panel
- Cardiovascular
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Special
- Location
- Atlanta, GA, US
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More clearances from Cybercare, Inc.
view allAdverse events under product code DXN
product code DXN- Death
- 3
- Injury
- 169
- Malfunction
- 1,019
- Other
- 2
- Total
- 1,193
Source: openFDA MAUDE database, through . 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.