FDA 510(k) Application Details - K022132

Device Classification Name Ventilator, Continuous, Facility Use

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510(K) Number K022132
Device Name Ventilator, Continuous, Facility Use
Applicant SIEMENS MEDICAL SOLUTIONS USA, INC.
16 ELECTRONICS AVE.
DANVERS, MA 01923 US
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Contact RICHARD FLYNN
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Regulation Number 868.5895

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Classification Product Code CBK
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Date Received 07/01/2002
Decision Date 09/19/2002
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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