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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 a medical device manufactured by Shenzhen Comen Medical Instruments Co.,Ltd. It received FDA 510(k) clearance on 2019-12-13 under approval 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. It is manufactured by Shenzhen Comen Medical Instruments Co.,Ltd. The 510(k) number is K191106.

When was C50 and C80 Multi-parameter Patient Monitor approved by the FDA?

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

What company makes C50 and C80 Multi-parameter Patient Monitor?

C50 and C80 Multi-parameter Patient Monitor is manufactured by Shenzhen Comen Medical Instruments Co.,Ltd.

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.

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Related PubMed Literature

PMID: 40794850 Regulatory Approved Point-of-Care Diagnostics (FDA & Health Canada): A Comprehensive Framework for Analytical Validity, Clinical Validity, and Clinical Utility in Medical Devices. The journal of applied laboratory medicine (2025) PMID: 28216355 Innovative postmarket device evaluation using a quality registry to monitor thoracic endovascular aortic repair in the treatment of aortic dissection. Journal of vascular surgery (2017)

Other Devices by Shenzhen Comen Medical Instruments Co.,Ltd

K173454Multi-parameter Patient Monitor, models C30 K211619Multi-Parameter Patient Monitor 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)

Related Devices (Code: MHX)

K160981Patient MonitorEdan Instruments, Inc. K153707Nihon Kohden Vital Sign TelemeterNihon Kohden Corporation K160685Surveyor S4 Mobile MonitorMortara Instrument, Inc. K161531IntelliVue Patient Monitors MP2, MP5, MP5T, MP5SC, and Multi-Measurement Module X2; IntelliVue Patient Monitors MP20, MP30, MP40, MP50, MP60; IntelliVue Patient Monitors MP70, MP80, MP90;IntelliVue Patient Monitors MX400, MX430, MX450, MX500, MX550, MX600;IntelliVue Patient Monitors MX700, MX800Philips Medizin Systeme Boeblingen GmbH K153702M3290B Philips IntelliVue Information Center iXPhilips Medical Systems K160951Philips Efficia CMS200 Central Monitoring SystemPhilips Medical Systems

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.

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