FDA 510(k) Application Details - K051226

Device Classification Name Ventilator, Non-Continuous (Respirator)

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510(K) Number K051226
Device Name Ventilator, Non-Continuous (Respirator)
Applicant Cardinal Health
1430 WAUKEGAN ROAD, BLDG. KB
MCGAW PARK, IL US
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Contact SHARON NICHOLS
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Regulation Number 868.5905

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Classification Product Code BZD
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Date Received 05/12/2005
Decision Date 11/17/2005
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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