Cleared Traditional

Infinity CentralStation Wide, Infinity M300, Infinity M300+

K231477 · Draeger Medical Systems, Inc. · Cardiovascular
Oct 2023
Decision
148d
Days
Class 2
Risk

About This 510(k) Submission

K231477 is an FDA 510(k) clearance for the Infinity CentralStation Wide, Infinity M300, Infinity M300+, a Monitor, Physiological, Patient(with Arrhythmia Detection Or Alarms) (Class II — Special Controls, product code MHX), submitted by Draeger Medical Systems, Inc. (Andover, US). The FDA issued a Cleared decision on October 17, 2023, 148 days after receiving the submission on May 22, 2023. This device falls under the Cardiovascular review panel. Regulated under 21 CFR 870.1025.

Submission Details

510(k) Number K231477 FDA.gov
FDA Decision Cleared SESE
Date Received May 22, 2023
Decision Date October 17, 2023
Days to Decision 148 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary Summary PDF

Device Classification

Product Code MHX — Monitor, Physiological, Patient(with Arrhythmia Detection Or Alarms)
Device Class Class II — Special Controls
CFR Regulation 21 CFR 870.1025

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