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FDA 510(k)

Integrated CardioRespiratory System

K-Number: K173156 · 2018-06-08

ApplicantSensydia, Inc.
Decision Date2018-06-08
Product CodeMWJ
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

Integrated CardioRespiratory System is a medical device manufactured by Sensydia, Inc.. It received FDA 510(k) clearance on 2018-06-08 under approval number K173156. The device is classified under product code MWJ. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Integrated CardioRespiratory System?

Integrated CardioRespiratory System is a medical device that received FDA 510(k) clearance on 2018-06-08. It is manufactured by Sensydia, Inc.. The 510(k) number is K173156.

When was Integrated CardioRespiratory System approved by the FDA?

Integrated CardioRespiratory System received FDA 510(k) clearance on 2018-06-08, under approval number K173156.

What company makes Integrated CardioRespiratory System?

Integrated CardioRespiratory System is manufactured by Sensydia, Inc..

What is the FDA product code for Integrated CardioRespiratory System?

The FDA product code for Integrated CardioRespiratory System is MWJ.

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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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