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FDA 510(k) Application Details - K020524
Device Classification Name
System,Network And Communication,Physiological Monitors
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510(K) Number
K020524
Device Name
System,Network And Communication,Physiological Monitors
Applicant
GENERAL ELECTRIC MEDICAL SYSTEMS INFORMATION TECHN
15222 DEL AMO AVE.
TUSTIN, CA 92780 US
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Contact
DIANA M THORSON
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Regulation Number
870.2300
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Classification Product Code
MSX
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More FDA Info for this Product Code
Date Received
02/19/2002
Decision Date
03/20/2002
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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