FDA 510(k) Application Details - K061931

Device Classification Name Oximeter

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510(K) Number K061931
Device Name Oximeter
Applicant SOLARIS MEDICAL TECHNOLOGY, INC.
2355 EAST FLAMINGO ROAD
SUITE 201 G
LAS VEGAS, NV 89119 US
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Contact THOMAS KROENKE
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Regulation Number 870.2700

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Classification Product Code DQA
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Date Received 07/07/2006
Decision Date 01/31/2007
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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