Identifiers
- 510(k) Number
- K011328 FDA 510(k)
- FDA Product Code
- LOS FDA 510(k)
Classification
- Advisory Committee
- Unknown FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
Cardio Care Ekg-2000 12-Channel Electrocardiograph by Bionet Company, Ltd. — FDA_510K — listed in FDA 510(k) — regulatory data on deviCERTS
Authorization Coverage (1 country)
Regulatory Authorizations
United States Active
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K011328 | N/A | Active |
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Manufacturer
- Manufacturer
- Bionet Company, Ltd.
Sources (1)
- FDA 510(k) K011328 24 fields · synced Jun 18, 2026