Cleared Traditional

Patient Monitor (iX10, iX12, iX15)

K232962 · Edan Instruments, Inc. · Cardiovascular
Apr 2024
Decision
211d
Days
Class 2
Risk

About This 510(k) Submission

K232962 is an FDA 510(k) clearance for the Patient Monitor (iX10, iX12, iX15), a Monitor, Physiological, Patient(with Arrhythmia Detection Or Alarms) (Class II — Special Controls, product code MHX), submitted by Edan Instruments, Inc. (Shenzhen, CN). The FDA issued a Cleared decision on April 19, 2024, 211 days after receiving the submission on September 21, 2023. This device falls under the Cardiovascular review panel. Regulated under 21 CFR 870.1025.

Submission Details

510(k) Number K232962 FDA.gov
FDA Decision Cleared SESE
Date Received September 21, 2023
Decision Date April 19, 2024
Days to Decision 211 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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