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FDA 510(k)

XactTrace Single Use Respiratory Effort Belt System

K-Number: K173793 · 2019-03-01

ApplicantEmbla Systems
Decision Date2019-03-01
Product CodeMNR
Advisory CommitteeAN
DecisionSubstantially Equivalent

Device Summary

XactTrace Single Use Respiratory Effort Belt System is a medical device manufactured by Embla Systems. It received FDA 510(k) clearance on 2019-03-01 under approval number K173793. The device is classified under product code MNR. It was reviewed by the AN advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the XactTrace Single Use Respiratory Effort Belt System?

XactTrace Single Use Respiratory Effort Belt System is a medical device that received FDA 510(k) clearance on 2019-03-01. It is manufactured by Embla Systems. The 510(k) number is K173793.

When was XactTrace Single Use Respiratory Effort Belt System approved by the FDA?

XactTrace Single Use Respiratory Effort Belt System received FDA 510(k) clearance on 2019-03-01, under approval number K173793.

What company makes XactTrace Single Use Respiratory Effort Belt System?

XactTrace Single Use Respiratory Effort Belt System is manufactured by Embla Systems.

What is the FDA product code for XactTrace Single Use Respiratory Effort Belt System?

The FDA product code for XactTrace Single Use Respiratory Effort Belt System is MNR.

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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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