FDA 510(k)

ASI Plethysmogrpah Analyzer

K-Number: K200567 · 2021-02-26

Decision Date2021-02-26

Product CodeJOM

Advisory CommitteeCV

DecisionSubstantially Equivalent

Device Summary

ASI Plethysmogrpah Analyzer is a medical device manufactured by Arterial Stiffness, Inc.. It received FDA 510(k) clearance on 2021-02-26 under approval number K200567. The device is classified under product code JOM. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ASI Plethysmogrpah Analyzer?

ASI Plethysmogrpah Analyzer is a medical device that received FDA 510(k) clearance on 2021-02-26. It is manufactured by Arterial Stiffness, Inc.. The 510(k) number is K200567.

When was ASI Plethysmogrpah Analyzer approved by the FDA?

ASI Plethysmogrpah Analyzer received FDA 510(k) clearance on 2021-02-26, under approval number K200567.

What company makes ASI Plethysmogrpah Analyzer?

ASI Plethysmogrpah Analyzer is manufactured by Arterial Stiffness, Inc..

What is the FDA product code for ASI Plethysmogrpah Analyzer?

The FDA product code for ASI Plethysmogrpah Analyzer is JOM.

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Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.