FDA 510(k) Application Details - K022103

Device Classification Name Spirometer, Diagnostic

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510(K) Number K022103
Device Name Spirometer, Diagnostic
Applicant PURITAN BENNETT CORP.
2200 FARADAY AVE.
CARLSBAD, CA 92008 US
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Contact JAMES BONDS
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Regulation Number 868.1840

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Classification Product Code BZG
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Date Received 06/28/2002
Decision Date 09/27/2002
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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