FDA 510(k)

physIQ Heart Rhythm and Respiratory Module

K-Number: K183322 · 2019-07-10

Decision Date2019-07-10

Product CodeDPS

Advisory CommitteeCV

DecisionSubstantially Equivalent

Device Summary

physIQ Heart Rhythm and Respiratory Module is a medical device manufactured by Physiq, Inc.. It received FDA 510(k) clearance on 2019-07-10 under approval number K183322. The device is classified under product code DPS. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the physIQ Heart Rhythm and Respiratory Module?

physIQ Heart Rhythm and Respiratory Module is a medical device that received FDA 510(k) clearance on 2019-07-10. It is manufactured by Physiq, Inc.. The 510(k) number is K183322.

When was physIQ Heart Rhythm and Respiratory Module approved by the FDA?

physIQ Heart Rhythm and Respiratory Module received FDA 510(k) clearance on 2019-07-10, under approval number K183322.

What company makes physIQ Heart Rhythm and Respiratory Module?

physIQ Heart Rhythm and Respiratory Module is manufactured by Physiq, Inc..

What is the FDA product code for physIQ Heart Rhythm and Respiratory Module?

The FDA product code for physIQ Heart Rhythm and Respiratory Module is DPS.

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Other Devices by Physiq, Inc.

K180234physiQ Heart Rhythm Module K193415physIQ Heart Rhythm and Respiration Module

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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.