MODIFICATION TO: ARGUS SYSTEM-CONTINUOUS EXPERT CARE NETWORK W/SMART ALRAMS

System, Network And Communication, Physiological Monitors

VISICU, INC.

The following data is part of a premarket notification filed by Visicu, Inc. with the FDA for Modification To: Argus System-continuous Expert Care Network W/smart Alrams.

Pre-market Notification Details

• Device ID: K012171
• 510k Number: K012171
• Device Name: MODIFICATION TO: ARGUS SYSTEM-CONTINUOUS EXPERT CARE NETWORK W/SMART ALRAMS
• Classification: System, Network And Communication, Physiological Monitors
• Applicant: VISICU, INC. 2400 BOSTON ST. Baltimore, MD 21224
• Contact: Michael Breslow
• Correspondent: Michael Breslow; VISICU, INC. 2400 BOSTON ST. Baltimore, MD 21224
• Product Code: MSX
• CFR Regulation Number: 870.2300 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Special
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 2001-07-12
• Decision Date: 2001-07-24

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
00884838087453	K012171	000
00884838059832	K012171	000
00884838059368	K012171	000