Cleared Traditional

K001972 - ARGUS SYSTEM-CONTINUOUS EXPERT CARE NETWORK (FDA 510(k) Clearance)

K001972 · Visicu, Inc. · Cardiovascular device

Oct 2000

Decision

121d

Days

Class 2

Risk

K001972 is an FDA 510(k) clearance for the ARGUS SYSTEM-CONTINUOUS EXPERT CARE NETWORK. This device is classified as a System, Network And Communication, Physiological Monitors (Class II - Special Controls, product code MSX).

Submitted by Visicu, Inc. (Lake Forest, US). The FDA issued a Cleared decision on October 27, 2000, 121 days after receiving the submission on June 28, 2000.

This device falls under the Cardiovascular FDA review panel. Regulated under 21 CFR 870.2300.

Submission Details

510(k) Number	K001972 FDA.gov
FDA Decision	Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received	June 28, 2000
Decision Date	October 27, 2000
Days to Decision	121 days
Submission Type	Traditional
Review Panel	Cardiovascular (CV)
Summary	Summary PDF