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510(k) K173793

XactTrace Single Use Respiratory Effort Belt System by Embla Systems — Product Code MNR

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 1, 2019
Date Received
December 14, 2017
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Ventilatory Effort Recorder
Device Class
Class II
Regulation Number
868.2375
Review Panel
AN
Submission Type

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