FDA 510(k) Application Details - K023494

Device Classification Name Ventilator, Emergency, Manual (Resuscitator)

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510(K) Number K023494
Device Name Ventilator, Emergency, Manual (Resuscitator)
Applicant NELLCOR PURITAN BENNETT, INC.
4280 HACIENDA DR.
PLEASANTON, CA 94588-2719 US
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Contact GINA TO
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Regulation Number 868.5915

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Classification Product Code BTM
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Date Received 10/18/2002
Decision Date 02/07/2003
Decision SESE - SUBST EQUIV
Classification Advisory Committee AN - Anesthesiology
Review Advisory Committee AN - Anesthesiology
Statement / Summary / Purged Status Summary
Type Special
Reviewed By Third Party N
Expedited Review



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