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510(k) K122516

EMBLETTA MPR by Embla Systems — Product Code MNR

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
February 21, 2013
Date Received
August 17, 2012
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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