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FDA 510(k) Application Details - K140605
Device Classification Name
Device, Positive Pressure Breathing, Intermittent
More FDA Info for this Device
510(K) Number
K140605
Device Name
Device, Positive Pressure Breathing, Intermittent
Applicant
DIMA ITALIA SRL
via Coriolano Vighi, 29
Bologna 40133 IT
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Contact
DARIO BASCIU
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Regulation Number
868.5905
More FDA Info for this Regulation Number
Classification Product Code
NHJ
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More FDA Info for this Product Code
Date Received
03/10/2014
Decision Date
10/03/2014
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
AN - Anesthesiology
Review Advisory Committee
AN - Anesthesiology
Statement / Summary / Purged Status
Summary
Type
Traditional
Reviewed By Third Party
N
Expedited Review
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