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FDA 510(k)

Tempus Pro Patient Monitor

K-Number: K173768 · 2018-01-10

ApplicantRemote Diagnostic Technologies , Ltd.
Decision Date2018-01-10
Product CodeMHX
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

Tempus Pro Patient Monitor is a medical device manufactured by Remote Diagnostic Technologies , Ltd.. It received FDA 510(k) clearance on 2018-01-10 under approval number K173768. 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 Tempus Pro Patient Monitor?

Tempus Pro Patient Monitor is a medical device that received FDA 510(k) clearance on 2018-01-10. It is manufactured by Remote Diagnostic Technologies , Ltd.. The 510(k) number is K173768.

When was Tempus Pro Patient Monitor approved by the FDA?

Tempus Pro Patient Monitor received FDA 510(k) clearance on 2018-01-10, under approval number K173768.

What company makes Tempus Pro Patient Monitor?

Tempus Pro Patient Monitor is manufactured by Remote Diagnostic Technologies , Ltd..

What is the FDA product code for Tempus Pro Patient Monitor?

The FDA product code for Tempus Pro Patient Monitor is MHX.

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Other Devices by Remote Diagnostic Technologies , Ltd.

K170567Tempus Pro Patient Monitor

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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