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FDA 510(k) Application Details - K100403
Device Classification Name
Oximeter
More FDA Info for this Device
510(K) Number
K100403
Device Name
Oximeter
Applicant
MASIMO CORPORATION
40 PARKER
IRVINE, CA 92618 US
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Contact
MARGUERITE THOMLINSON
Other 510(k) Applications for this Contact
Regulation Number
870.2700
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Classification Product Code
DQA
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More FDA Info for this Product Code
Date Received
02/16/2010
Decision Date
06/23/2010
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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