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FDA 510(k)

Tempus Pro Patient Monitor

K-Number: K201746 · 2020-09-18

ApplicantRemote Diagnostic Technologies Limited
Decision Date2020-09-18
Product CodeMHX
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

Tempus Pro Patient Monitor is a medical device manufactured by Remote Diagnostic Technologies Limited. It received FDA 510(k) clearance on 2020-09-18 under approval number K201746. 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 2020-09-18. It is manufactured by Remote Diagnostic Technologies Limited. The 510(k) number is K201746.

When was Tempus Pro Patient Monitor approved by the FDA?

Tempus Pro Patient Monitor received FDA 510(k) clearance on 2020-09-18, under approval number K201746.

What company makes Tempus Pro Patient Monitor?

Tempus Pro Patient Monitor is manufactured by Remote Diagnostic Technologies Limited.

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

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