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FDA 510(k) Application Details - K093280
Device Classification Name
Electrode Measurement, Blood-Gases (Pco2, Po2) And Blood Ph
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510(K) Number
K093280
Device Name
Electrode Measurement, Blood-Gases (Pco2, Po2) And Blood Ph
Applicant
OPTI MEDICAL SYSTEMS INC.
235 HEMBREE PARK DRIVE
ROSWELL, GA 30076 US
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Contact
LEN OWENS
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Regulation Number
862.1120
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Classification Product Code
CHL
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More FDA Info for this Product Code
Date Received
10/20/2009
Decision Date
01/07/2011
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
CH - Clinical Chemistry
Review Advisory Committee
CH - Clinical Chemistry
Statement / Summary / Purged Status
Summary
Type
Traditional
Reviewed By Third Party
N
Expedited Review
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