CV3000 HOLTER ANALYSIS SYSTEM— 510(k) K131897

Substantially Equivalent

Vales & Hills Biomedical Tech. , Ltd.

FDA 510(k) clearance K131897 for CV3000 HOLTER ANALYSIS SYSTEM, Substantially Equivalent on 2013-11-26. Applicant: Vales & Hills Biomedical Tech. , Ltd..

Clearance details

Applicant: Vales & Hills Biomedical Tech. , Ltd.
Product code: Code MLO
Advisory panel: Cardiovascular
Date received: 2013-06-25
Decision date: 2013-11-26
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Shanghai, CN

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