FDA 510(k) Application Details - K980441

Device Classification Name Spirometer, Diagnostic

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510(K) Number K980441
Device Name Spirometer, Diagnostic
Applicant NELLCOR PURITAN BENNETT, INC.
11150 THOMPSON AVE.
LENEXA, KS 66219-2301 US
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Contact DAVID GREEN
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Regulation Number 868.1840

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Classification Product Code BZG
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Date Received 02/04/1998
Decision Date 04/30/1998
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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