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FDA 510(k)

Nihon Kohden Vital Sign Telemeter

K-Number: K163459 · 2017-04-04

ApplicantNihon Kohden Corporation
Decision Date2017-04-04
Product CodeMHX
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

Nihon Kohden Vital Sign Telemeter is a medical device manufactured by Nihon Kohden Corporation. It received FDA 510(k) clearance on 2017-04-04 under approval number K163459. 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 Nihon Kohden Vital Sign Telemeter?

Nihon Kohden Vital Sign Telemeter is a medical device that received FDA 510(k) clearance on 2017-04-04. It is manufactured by Nihon Kohden Corporation. The 510(k) number is K163459.

When was Nihon Kohden Vital Sign Telemeter approved by the FDA?

Nihon Kohden Vital Sign Telemeter received FDA 510(k) clearance on 2017-04-04, under approval number K163459.

What company makes Nihon Kohden Vital Sign Telemeter?

Nihon Kohden Vital Sign Telemeter is manufactured by Nihon Kohden Corporation.

What is the FDA product code for Nihon Kohden Vital Sign Telemeter?

The FDA product code for Nihon Kohden Vital Sign Telemeter is MHX.

Other Devices by Nihon Kohden Corporation

K153707Nihon Kohden Vital Sign Telemeter K152305Nihon Kohden Afib Detection Program QP-039P K171765Nihon Kohden CO2 Monitor K171124Nihon Kohden Wireless Input Unit WEE-1200 K163644Nihon Kohden QP-160AK EEG Trend Program K161860TG-970P CO2 Sensor Kit

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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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