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FDA 510(k) Application Details - K100523
Device Classification Name
Oximeter, Tissue Saturation, Reprocessed
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510(K) Number
K100523
Device Name
Oximeter, Tissue Saturation, Reprocessed
Applicant
HYGIA HEALTH SERVICES, INC.
434 INDUSTRIAL LN.
BIRMINGHAM, AL 35211 US
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Contact
LAKE TRECHSEL
Other 510(k) Applications for this Contact
Regulation Number
870.2700
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Classification Product Code
NMD
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More FDA Info for this Product Code
Date Received
02/24/2010
Decision Date
05/04/2010
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
CV - Cardiovascular
Review Advisory Committee
CV - Cardiovascular
Statement / Summary / Purged Status
Summary
Type
Traditional
Reviewed By Third Party
N
Expedited Review
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