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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 the device name listed in this FDA 510(k) record. The listed applicant is Embla Systems. It received FDA 510(k) clearance on 2019-03-01 under 510(k) 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. The listed applicant is Embla Systems. The 510(k) number is K173793.

When did XactTrace Single Use Respiratory Effort Belt System receive FDA 510(k) clearance?

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

Who is the listed applicant for XactTrace Single Use Respiratory Effort Belt System?

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

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.

Other records listing Embla Systems as applicant

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.

K180001Disposable BreathSensor Adult, Disposable BreathSensor Small Adult / Child, Disposable BreathSensor Preemie, Disposable BreathSensor InfantK172703Disposable Snap ElectrodeK163617REMbrandtK162140RemLogicK153353SANDMAN ELITE

Related Devices (Code: MNR)

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.

K254042WatchPAT SWItamar Medical , Ltd.K260050WRAP SystemHuneo, LLCK253148RX-1 SleepVivaquant, Inc. Dba Rhythm ExpressK252628CASSIEWesper, Inc.K252497SANSA HSATHuxley MedicalK250882SANSA HSATHuxley Medical

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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