Cleared Traditional

Infinity CentralStation Wide

K240312 · Draeger Medical Systems, Inc. · Cardiovascular
Aug 2024
Decision
181d
Days
Class 2
Risk

About This 510(k) Submission

K240312 is an FDA 510(k) clearance for the Infinity CentralStation Wide, 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 August 1, 2024, 181 days after receiving the submission on February 2, 2024. This device falls under the Cardiovascular review panel. Regulated under 21 CFR 870.1025.

Submission Details

510(k) Number K240312 FDA.gov
FDA Decision Cleared SESE
Date Received February 02, 2024
Decision Date August 01, 2024
Days to Decision 181 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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