FDA 510(k) Application Details - K052544

Device Classification Name Oximeter

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510(K) Number K052544
Device Name Oximeter
Applicant AMERICAN I.V. PRODUCTS, INC.
7485 SHIPLEY AVE.
HANOVER, MD 21076 US
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Contact GREGORY FALK
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Regulation Number 870.2700

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Classification Product Code DQA
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Date Received 09/15/2005
Decision Date 09/29/2006
Decision SESE - SUBST EQUIV
Classification Advisory Committee CV - Cardiovascular
Review Advisory Committee AN - Anesthesiology
Statement / Summary / Purged Status Summary
Type Abbreviated
Reviewed By Third Party N
Expedited Review



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