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510(k) K061996

SANDMAN POCKET by Eb Neuro S.P.A. — Product Code MNR

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 3, 2006
Date Received
July 14, 2006
Clearance Type
Traditional
Expedited Review
No
Third Party Review
Yes

Device Classification

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

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