FDA 510(k) Application Details - K002001

Device Classification Name Ventilator, Non-Continuous (Respirator)

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510(K) Number K002001
Device Name Ventilator, Non-Continuous (Respirator)
Applicant PURITAN BENNETT CORP.
2800 NORTHWEST BLVD.
MINNEAPOLIS, MN 55441 US
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Contact DARIN BUSCH
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Regulation Number 868.5905

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Classification Product Code BZD
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Date Received 06/30/2000
Decision Date 09/06/2000
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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