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FDA 510(k)

Cardiovascular Analzyer

K-Number: K172431 · 2018-03-14

ApplicantPhysiowave, Inc.
Decision Date2018-03-14
Product CodeDSB
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

Cardiovascular Analzyer is the device name listed in this FDA 510(k) record. The listed applicant is Physiowave, Inc.. It received FDA 510(k) clearance on 2018-03-14 under 510(k) number K172431. The device is classified under product code DSB. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Cardiovascular Analzyer?

Cardiovascular Analzyer is a medical device that received FDA 510(k) clearance on 2018-03-14. The listed applicant is Physiowave, Inc.. The 510(k) number is K172431.

When did Cardiovascular Analzyer receive FDA 510(k) clearance?

Cardiovascular Analzyer received FDA 510(k) clearance on 2018-03-14, under 510(k) number K172431.

Who is the listed applicant for Cardiovascular Analzyer?

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

What is the FDA product code for Cardiovascular Analzyer?

The FDA product code for Cardiovascular Analzyer is DSB.

Related Devices (Code: DSB)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

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Official Source

View on FDA Database →

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

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