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FDA 510(k) Application Details - K003622
Device Classification Name
Monitor,Physiological,Patient(Without Arrhythmia Detection Or Alarms)
More FDA Info for this Device
510(K) Number
K003622
Device Name
Monitor,Physiological,Patient(Without Arrhythmia Detection Or Alarms)
Applicant
AGILENT TECHNOLOGIES, INC.
3000 MINUTEMAN RD.
ANDOVER, MA 01810-1099 US
Other 510(k) Applications for this Company
Contact
MIKE HUDON
Other 510(k) Applications for this Contact
Regulation Number
870.2300
More FDA Info for this Regulation Number
Classification Product Code
MWI
Other 510(k) Applications for this Device
More FDA Info for this Product Code
Date Received
11/24/2000
Decision Date
12/18/2000
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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