Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

FDA 510(k)

C50 and C80 Multi-parameter Patient Monitor

K-Number: K191106 · 2019-12-13

ApplicantShenzhen Comen Medical Instruments Co.,Ltd
Decision Date2019-12-13
Product CodeMHX
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

C50 and C80 Multi-parameter Patient Monitor is the device name listed in this FDA 510(k) record. The listed applicant is Shenzhen Comen Medical Instruments Co.,Ltd. It received FDA 510(k) clearance on 2019-12-13 under 510(k) number K191106. The device is classified under product code MHX. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the C50 and C80 Multi-parameter Patient Monitor?

C50 and C80 Multi-parameter Patient Monitor is a medical device that received FDA 510(k) clearance on 2019-12-13. The listed applicant is Shenzhen Comen Medical Instruments Co.,Ltd. The 510(k) number is K191106.

When did C50 and C80 Multi-parameter Patient Monitor receive FDA 510(k) clearance?

C50 and C80 Multi-parameter Patient Monitor received FDA 510(k) clearance on 2019-12-13, under 510(k) number K191106.

Who is the listed applicant for C50 and C80 Multi-parameter Patient Monitor?

The FDA 510(k) record lists Shenzhen Comen Medical Instruments Co.,Ltd as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for C50 and C80 Multi-parameter Patient Monitor?

The FDA product code for C50 and C80 Multi-parameter Patient Monitor is MHX.

Other records listing Shenzhen Comen Medical Instruments Co.,Ltd as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K250854Multi-parameter Patient Monitor (N10); Multi-parameter Patient Monitor (N12); Multi-parameter Patient Monitor (N15); Multi-parameter Patient Monitor (N10MPro); Multi-parameter Patient Monitor (N12MPro); Multi-parameter Patient Monitor (N15MPro)K250190Sequential Compression System (SCD600)K211619Multi-Parameter Patient MonitorK173454Multi-parameter Patient Monitor, models C30

Related Devices (Code: MHX)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K251508Telemetry Monitor (iT30, iT50)Edan Instruments, Inc.K253277Monitor B105M; Monitor B125M; Monitor B155M; Monitor B105P; Monitor B125PGe Medical Systems Information Technologies, Inc.K254209Radius VSM and AccessoriesMasimo CorporationK252840M12 Telemetry SystemGlobal Instrumentation, LLCK260098ePM Series Patient Monitor (ePM 10/ePM 10A/ePM 10C/Guardian plus/ ePM 12/ePM 12A/ePM 12C / ePM 15/ePM 15A/ePM 15C /ePM 10M/ ePM 10MA/ ePM 10MC/ePM 12M/ ePM 12MA/ ePM 12MC/ePM 15M/ ePM 15MA/ ePM 15MC)Shenzhen Mindray Bio-Medical Electronics Co., Ltd.K250349Vista CMSShanghai Draeger Medical Instrument Co., Ltd.

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

↑