Cleared Traditional

Multi-Parameter Patient Monitor

K211619 · Shenzhen Comen Medical Instruments Co.,Ltd · Cardiovascular
Dec 2022
Decision
582d
Days
Class 2
Risk

About This 510(k) Submission

K211619 is an FDA 510(k) clearance for the Multi-Parameter Patient Monitor, a Monitor, Physiological, Patient(with Arrhythmia Detection Or Alarms) (Class II — Special Controls, product code MHX), submitted by Shenzhen Comen Medical Instruments Co.,Ltd (Shenzhen, CN). The FDA issued a Cleared decision on December 29, 2022, 582 days after receiving the submission on May 26, 2021. This device falls under the Cardiovascular review panel. Regulated under 21 CFR 870.1025.

Submission Details

510(k) Number K211619 FDA.gov
FDA Decision Cleared SESE
Date Received May 26, 2021
Decision Date December 29, 2022
Days to Decision 582 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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