ASI Plethysmogrpah Analyzer— 510(k) K200567

Name: FDA 510(k) clearance K200567
Creator: U.S. Food and Drug Administration
Published: 2021-02-26

Substantially Equivalent

Arterial Stiffness, Inc.

FDA 510(k) clearance K200567 for ASI Plethysmogrpah Analyzer, Substantially Equivalent on 2021-02-26. Applicant: Arterial Stiffness, Inc.. Device class: 2.

Clearance details

Applicant: Arterial Stiffness, Inc.
Product code: Code JOM
Device class: Class 2
Regulation: 21 CFR 870.2780
Advisory panel: Cardiovascular
Date received: 2020-03-04
Decision date: 2021-02-26
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Saint Paul, MN, US

Download summary PDF View on FDA.gov ↗

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