FDA 510(k) Application Details - K023225

Device Classification Name Spirometer, Diagnostic

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510(K) Number K023225
Device Name Spirometer, Diagnostic
Applicant PURITAN BENNETT CORP.
4280 HACIENDA DR.
PLEASANTON, CA 94588-2719 US
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Contact GINA TO
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Regulation Number 868.1840

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Classification Product Code BZG
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Date Received 09/27/2002
Decision Date 12/18/2002
Decision SESE - SUBST EQUIV
Classification Advisory Committee AN - Anesthesiology
Review Advisory Committee AN - Anesthesiology
Statement / Summary / Purged Status Summary
Type Abbreviated
Reviewed By Third Party N
Expedited Review



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