FDA 510(k) Application Details - K061450

Device Classification Name Catheter, Oximeter, Fiberoptic

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510(K) Number K061450
Device Name Catheter, Oximeter, Fiberoptic
Applicant HOSPIRA, INC.
275 NORTH FIELD DR.
LAKE FOREST, IL 60045 US
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Contact THOMAS SAMPOGNA
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Regulation Number 870.1230

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Classification Product Code DQE
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Date Received 05/25/2006
Decision Date 08/04/2006
Decision SESE - SUBST EQUIV
Classification Advisory Committee CV - Cardiovascular
Review Advisory Committee CV - Cardiovascular
Statement / Summary / Purged Status Summary
Type Traditional
Reviewed By Third Party N
Expedited Review



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