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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name System, Network And Communication, Physiological Monitors
510(k) Number K012171
Device Name MODIFICATION TO: ARGUS SYSTEM-CONTINUOUS EXPERT CARE NETWORK W/SMART ALRAMS
Applicant
Visicu, Inc.
2400 Boston St.
Baltimore,  MD  21224
Applicant Contact MICHAEL BRESLOW
Correspondent
Visicu, Inc.
2400 Boston St.
Baltimore,  MD  21224
Correspondent Contact MICHAEL BRESLOW
Regulation Number870.2300
Classification Product Code
MSX  
Date Received07/12/2001
Decision Date 07/24/2001
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Statement Statement
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
Recalls CDRH Recalls
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