Cleared Traditional

Infinity Gateway Suite

K233834 · Draeger Medical Systems, Inc. · Cardiovascular
Jul 2024
Decision
221d
Days
Class 2
Risk

About This 510(k) Submission

K233834 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 July 12, 2024, 221 days after receiving the submission on December 4, 2023. This device falls under the Cardiovascular review panel. Regulated under 21 CFR 870.2300.

Submission Details

510(k) Number K233834 FDA.gov
FDA Decision Cleared SESE
Date Received December 04, 2023
Decision Date July 12, 2024
Days to Decision 221 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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