Cleared Traditional

Multi-parameter Patient Monitor, models C30

K173454 · Shenzhen Comen Medical Instruments Co.,Ltd · Cardiovascular
Aug 2018
Decision
283d
Days
Class 2
Risk

About This 510(k) Submission

K173454 is an FDA 510(k) clearance for the Multi-parameter Patient Monitor, models C30, 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 August 16, 2018, 283 days after receiving the submission on November 6, 2017. This device falls under the Cardiovascular review panel. Regulated under 21 CFR 870.1025.

Submission Details

510(k) Number K173454 FDA.gov
FDA Decision Cleared SESE
Date Received November 06, 2017
Decision Date August 16, 2018
Days to Decision 283 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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