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FDA 510(k)

Patient Monitor (CX10, CX12, CX15, UX10, UX12, UX15)

K-Number: K250179 · 2025-07-29

ApplicantEdan Instruments, Inc.
Decision Date2025-07-29
Product CodeMHX
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

Patient Monitor (CX10, CX12, CX15, UX10, UX12, UX15) is a medical device manufactured by Edan Instruments, Inc.. It received FDA 510(k) clearance on 2025-07-29 under approval number K250179. 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 Patient Monitor (CX10, CX12, CX15, UX10, UX12, UX15)?

Patient Monitor (CX10, CX12, CX15, UX10, UX12, UX15) is a medical device that received FDA 510(k) clearance on 2025-07-29. It is manufactured by Edan Instruments, Inc.. The 510(k) number is K250179.

When was Patient Monitor (CX10, CX12, CX15, UX10, UX12, UX15) approved by the FDA?

Patient Monitor (CX10, CX12, CX15, UX10, UX12, UX15) received FDA 510(k) clearance on 2025-07-29, under approval number K250179.

What company makes Patient Monitor (CX10, CX12, CX15, UX10, UX12, UX15)?

Patient Monitor (CX10, CX12, CX15, UX10, UX12, UX15) is manufactured by Edan Instruments, Inc..

What is the FDA product code for Patient Monitor (CX10, CX12, CX15, UX10, UX12, UX15)?

The FDA product code for Patient Monitor (CX10, CX12, CX15, UX10, UX12, UX15) is MHX.

Related Clinical Trials

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Other Devices by Edan Instruments, Inc.

K160981Patient Monitor K151978EDAN i15 Blood Gas and Chemistry Analysis System, EDAN i15 Calibrant Fluid Pack, EDAN i15 Blood Gas and Electrolyte Control, EDAN i15 Hematocrit Control K161302PC ECG K161300Acclarix AX8 Diagnostic Ultrasound System K152552Patient Monitor K160790Acclarix LX8 Diagnostic Ultrasound System

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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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