FDA 510(k) Application Details - K960251

Device Classification Name Oximeter

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510(K) Number K960251
Device Name Oximeter
Applicant ARISTO MEDICAL PRODUCTS, INC.
407 PILOT CT., #400-A
WAUKESHA, WI 53188 US
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Contact STEPHEN H GORSKI
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Regulation Number 870.2700

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Classification Product Code DQA
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Date Received 01/18/1996
Decision Date 03/26/1996
Decision SESE - SUBST EQUIV
Classification Advisory Committee CV - Cardiovascular
Review Advisory Committee AN - Anesthesiology
Statement / Summary / Purged Status Statement
Type Traditional
Reviewed By Third Party N
Expedited Review



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