FDA 510(k) Application Details - K072292

Device Classification Name Device, Positive Pressure Breathing, Intermittent

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510(K) Number K072292
Device Name Device, Positive Pressure Breathing, Intermittent
Applicant DIMA ITALIA SRL
4655 KIRKWOOD CT.
BOULDER, CO 80301 US
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Contact LEWIS WARD
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Regulation Number 868.5905

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Classification Product Code NHJ
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Date Received 08/16/2007
Decision Date 01/07/2008
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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