FDA 510(k) Application Details - K073249

Device Classification Name Oximeter

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510(K) Number K073249
Device Name Oximeter
Applicant SOLARIS MEDICAL TECHNOLOGY, INC.
55 Northern Blvd.
Suite 200
Great Neck, NY 11021 US
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Contact ALAN SCHWARTZ
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Regulation Number 870.2700

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Classification Product Code DQA
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Date Received 11/19/2007
Decision Date 07/25/2008
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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