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FDA 510(k) Application Details - K013156
Device Classification Name
System,Network And Communication,Physiological Monitors
More FDA Info for this Device
510(K) Number
K013156
Device Name
System,Network And Communication,Physiological Monitors
Applicant
DATA CRITICAL CORP.
19820 NORTH CREEK PKWY.
#100
BOTHELL, WA 98011 US
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Contact
TERESA DAVIDSON
Other 510(k) Applications for this Contact
Regulation Number
870.2300
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Classification Product Code
MSX
Other 510(k) Applications for this Device
More FDA Info for this Product Code
Date Received
09/21/2001
Decision Date
10/19/2001
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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