FDA 510(k) Application Details - K972468

Device Classification Name Oximeter

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510(K) Number K972468
Device Name Oximeter
Applicant NELLCOR PURITAN BENNETT, INC.
11150 THOMPSON AVE.
LENEXA, KS 66219-2301 US
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Contact ROGER D BROWN
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Regulation Number 870.2700

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Classification Product Code DQA
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Date Received 07/01/1997
Decision Date 09/25/1997
Decision SESE - SUBST EQUIV
Classification Advisory Committee CV - Cardiovascular
Review Advisory Committee AN - Anesthesiology
Statement / Summary / Purged Status Summary
Type Traditional
Reviewed By Third Party N
Expedited Review



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