Argus System-Continuous Expert Care Network

FDA 510(k) K001972 · Visicu, Inc.

Substantially Equivalent

510(k) numberK001972

Submission

Device name
Argus System-Continuous Expert Care Network
Applicant
Visicu, Inc.
Lake Forest, CA, US
Received
June 28, 2000
Decision date
October 27, 2000
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)
Summary
510(k) summary available from FDA

Official FDA 510(k) record

Device classification

Product code
MSX – System, Network And Communication, Physiological Monitors
Device class
Class II (moderate risk)
Regulation
21 CFR 870.2300
Specialty
Cardiovascular
Life-sustaining
Yes

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More from Draeger Medical Systems, Inc.

510(k)DeviceDecision
K211046eCareManager 4.5MSX · Traditional 06/03/2022SE
K171322eCareManager 4.1MSX · Traditional 08/03/2017SE
K171029eCareCoordinatorDRG · Traditional 07/14/2017SE
K153156eCareManager 4.0.1MSX · Traditional 09/30/2016SE
K141706Ecare Coordinator (Ecc)DRG · Traditional 09/09/2014SE
K012171Modification to: Argus System-Continuous Expert Care Network W/Smart AlramsMSX · Special 07/24/2001SE

Questions and answers

When was Argus System-Continuous Expert Care Network cleared by the FDA?

Argus System-Continuous Expert Care Network (K001972) received a 510(k) decision of Substantially Equivalent on October 27, 2000, 121 days after the submission was received.

What is the product code of K001972?

The FDA product code is MSX – System, Network And Communication, Physiological Monitors, a Class II (moderate risk) device regulated under 21 CFR 870.2300.