FDA 510(k) Application Details - K061191

Device Classification Name Oximeter

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510(K) Number K061191
Device Name Oximeter
Applicant MEASUREMENT SPECIALTIES, INC.
2300 MCDERMOTT ROAD
# 200-207
PLANO, TX 75025 US
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Contact KRISTA OAKES
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Regulation Number 870.2700

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Classification Product Code DQA
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Date Received 04/28/2006
Decision Date 05/22/2006
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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