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510(k) K111742

MDRIVE by Embla Systems — Product Code MNR

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 31, 2011
Date Received
June 21, 2011
Clearance Type
Special
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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