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FDA 510(k)

Multi-parameter Patient Monitor, models C30

K-Number: K173454 · 2018-08-16

ApplicantShenzhen Comen Medical Instruments Co.,Ltd
Decision Date2018-08-16
Product CodeMHX
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

Multi-parameter Patient Monitor, models C30 is a medical device manufactured by Shenzhen Comen Medical Instruments Co.,Ltd. It received FDA 510(k) clearance on 2018-08-16 under approval number K173454. 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 Multi-parameter Patient Monitor, models C30?

Multi-parameter Patient Monitor, models C30 is a medical device that received FDA 510(k) clearance on 2018-08-16. It is manufactured by Shenzhen Comen Medical Instruments Co.,Ltd. The 510(k) number is K173454.

When was Multi-parameter Patient Monitor, models C30 approved by the FDA?

Multi-parameter Patient Monitor, models C30 received FDA 510(k) clearance on 2018-08-16, under approval number K173454.

What company makes Multi-parameter Patient Monitor, models C30?

Multi-parameter Patient Monitor, models C30 is manufactured by Shenzhen Comen Medical Instruments Co.,Ltd.

What is the FDA product code for Multi-parameter Patient Monitor, models C30?

The FDA product code for Multi-parameter Patient Monitor, models C30 is MHX.

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Other Devices by Shenzhen Comen Medical Instruments Co.,Ltd

K191106C50 and C80 Multi-parameter Patient Monitor 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

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