Cleared Traditional

C50 and C80 Multi-parameter Patient Monitor

K191106 · Shenzhen Comen Medical Instruments Co.,Ltd · Cardiovascular
Dec 2019
Decision
232d
Days
Class 2
Risk

About This 510(k) Submission

K191106 is an FDA 510(k) clearance for the C50 and C80 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 13, 2019, 232 days after receiving the submission on April 25, 2019. This device falls under the Cardiovascular review panel. Regulated under 21 CFR 870.1025.

Submission Details

510(k) Number K191106 FDA.gov
FDA Decision Cleared SESE
Date Received April 25, 2019
Decision Date December 13, 2019
Days to Decision 232 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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