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FDA 510(k) Application Details - K020075
Device Classification Name
Oximeter
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510(K) Number
K020075
Device Name
Oximeter
Applicant
DOLPHIN MEDICAL INC.
13801 MCCORMICK DR.
TAMPA, FL 33626 US
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Contact
JON WERNER
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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
01/09/2002
Decision Date
02/08/2002
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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