FDA 510(k) Application Details - K092950

Device Classification Name Oximeter

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510(K) Number K092950
Device Name Oximeter
Applicant SOLARIS MEDICAL TECHNOLOGY, INC.
55 Northern Blvd.
Suite 200
Great Neck, NY 11021 US
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Contact SUSAN D GOLDSTEIN-FALK
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Regulation Number 870.2700

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Classification Product Code DQA
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Date Received 09/24/2009
Decision Date 03/12/2010
Decision SESE - SUBST EQUIV
Classification Advisory Committee CV - Cardiovascular
Review Advisory Committee AN - Anesthesiology
Statement / Summary / Purged Status Summary
Type Special
Reviewed By Third Party N
Expedited Review



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