XactTrace Single Use Respiratory Effort Belt System— 510(k) K173793

Substantially Equivalent

Embla Systems

FDA 510(k) clearance K173793 for XactTrace Single Use Respiratory Effort Belt System, Substantially Equivalent on 2019-03-01. Applicant: Embla Systems.

Clearance details

Applicant: Embla Systems
Product code: Code MNR
Advisory panel: Anesthesiology
Date received: 2017-12-14
Decision date: 2019-03-01
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Kanata, CA

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