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FDA 510(k)

ASI Plethysmogrpah Analyzer

K-Number: K200567 · 2021-02-26

ApplicantArterial Stiffness, Inc.
Decision Date2021-02-26
Product CodeJOM
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

ASI Plethysmogrpah Analyzer is the device name listed in this FDA 510(k) record. The listed applicant is Arterial Stiffness, Inc.. It received FDA 510(k) clearance on 2021-02-26 under 510(k) 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. The listed applicant is Arterial Stiffness, Inc.. The 510(k) number is K200567.

When did ASI Plethysmogrpah Analyzer receive FDA 510(k) clearance?

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

Who is the listed applicant for ASI Plethysmogrpah Analyzer?

The FDA 510(k) record lists Arterial Stiffness, Inc. as the applicant. This does not by itself establish the device manufacturer.

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.

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