Cleared Traditional

Patient Monitor

K202336 · Edan Instruments, Inc. · Cardiovascular
Jan 2021
Decision
159d
Days
Class 2
Risk

About This 510(k) Submission

K202336 is an FDA 510(k) clearance for the Patient Monitor, 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 January 23, 2021, 159 days after receiving the submission on August 17, 2020. This device falls under the Cardiovascular review panel. Regulated under 21 CFR 870.1025.

Submission Details

510(k) Number K202336 FDA.gov
FDA Decision Cleared SESE
Date Received August 17, 2020
Decision Date January 23, 2021
Days to Decision 159 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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