Cleared Traditional

MONITORING SYSTEM, MODEL ARGUS PB-2200

K033738 · Schiller AG · Cardiovascular
Aug 2004
Decision
270d
Days
Class 2
Risk

About This 510(k) Submission

K033738 is an FDA 510(k) clearance for the MONITORING SYSTEM, MODEL ARGUS PB-2200, a Computer, Blood-pressure (Class II — Special Controls, product code DSK), submitted by Schiller AG (Baar, CH). The FDA issued a Cleared decision on August 24, 2004, 270 days after receiving the submission on November 28, 2003. This device falls under the Cardiovascular review panel. Regulated under 21 CFR 870.1110.

Submission Details

510(k) Number K033738 FDA.gov
FDA Decision Cleared SESE
Date Received November 28, 2003
Decision Date August 24, 2004
Days to Decision 270 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary Summary PDF

Device Classification

Product Code DSK — Computer, Blood-pressure
Device Class Class II — Special Controls
CFR Regulation 21 CFR 870.1110

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