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FDA 510(k) Application Details - K081233
Device Classification Name
Oximeter, Tissue Saturation
More FDA Info for this Device
510(K) Number
K081233
Device Name
Oximeter, Tissue Saturation
Applicant
SPECTROS CORPORATION
9433 SOUTH MORNING GLORY LANE
HIGHLANDS RANCH, CO 80130 US
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Contact
BILL CURNAN
Other 510(k) Applications for this Contact
Regulation Number
870.2700
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Classification Product Code
MUD
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More FDA Info for this Product Code
Date Received
05/01/2008
Decision Date
07/28/2008
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
CV - Cardiovascular
Review Advisory Committee
CV - Cardiovascular
Statement / Summary / Purged Status
Summary
Type
Special
Reviewed By Third Party
N
Expedited Review
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