CARDIO CARE EKG-2000 12-CHANNEL ELECTROCARDIOGRAPH— 510(k) K011328

Name: FDA 510(k) clearance K011328
Creator: U.S. Food and Drug Administration
Published: 2001-11-21

Substantially Equivalent

Bionet Company, Ltd.

FDA 510(k) clearance K011328 for CARDIO CARE EKG-2000 12-CHANNEL ELECTROCARDIOGRAPH, Substantially Equivalent on 2001-11-21. Applicant: Bionet Company, Ltd..

Clearance details

Applicant: Bionet Company, Ltd.
Product code: Code LOS
Advisory panel: Unknown
Date received: 2001-05-01
Decision date: 2001-11-21
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Seoul, KR

Download summary PDF View on FDA.gov ↗

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