Cleared Traditional

Infinity Gateway Suite

K203579 · Draeger Medical Systems, Inc. · Cardiovascular
Jun 2022
Decision
547d
Days
Class 2
Risk

About This 510(k) Submission

K203579 is an FDA 510(k) clearance for the Infinity Gateway Suite, a System, Network And Communication, Physiological Monitors (Class II — Special Controls, product code MSX), submitted by Draeger Medical Systems, Inc. (Andover, US). The FDA issued a Cleared decision on June 7, 2022, 547 days after receiving the submission on December 7, 2020. This device falls under the Cardiovascular review panel. Regulated under 21 CFR 870.2300.

Submission Details

510(k) Number K203579 FDA.gov
FDA Decision Cleared SESE
Date Received December 07, 2020
Decision Date June 07, 2022
Days to Decision 547 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary Summary PDF

Device Classification

Product Code MSX — System, Network And Communication, Physiological Monitors
Device Class Class II — Special Controls
CFR Regulation 21 CFR 870.2300

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