CV3000 HOLTER ANALYSIS SYSTEM— 510(k) K131897

Name: FDA 510(k) clearance K131897
Creator: U.S. Food and Drug Administration
Published: 2013-11-26

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.. Device class: 2.

Clearance details

Applicant: Vales & Hills Biomedical Tech. , Ltd.
Product code: Code MLO
Device class: Class 2
Regulation: 21 CFR 870.2800
Advisory panel: Cardiovascular
Date received: 2013-06-25
Decision date: 2013-11-26
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Shanghai, CN

Download summary PDF View on FDA.gov ↗

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