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FDA 510(k)

Patient Monitor

K-Number: K160981 · 2016-12-22

ApplicantEdan Instruments, Inc.
Decision Date2016-12-22
Product CodeMHX
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

Patient Monitor is a medical device manufactured by Edan Instruments, Inc.. It received FDA 510(k) clearance on 2016-12-22 under approval number K160981. 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?

Patient Monitor is a medical device that received FDA 510(k) clearance on 2016-12-22. It is manufactured by Edan Instruments, Inc.. The 510(k) number is K160981.

When was Patient Monitor approved by the FDA?

Patient Monitor received FDA 510(k) clearance on 2016-12-22, under approval number K160981.

What company makes Patient Monitor?

Patient Monitor is manufactured by Edan Instruments, Inc..

What is the FDA product code for Patient Monitor?

The FDA product code for Patient Monitor is MHX.

Related Clinical Trials

NCT07614139 Continuous Glucose Monitoring Alerts, Accuracy, and Patient Outcomes in Adults With Inherited Metabolic Disorders COMPLETED NCT07301385 Evaluation of Head-Mounted Spatial Computing and Three-Dimensional (3D) Visualization in Ocular Microsurgery: A Safety and Workflow Study ACTIVE_NOT_RECRUITING NCT07606495 Impact on Prognosis of Increased Sleep Quality Obtained by Personalized Night-time Nursing Care in Critically Ill Patients NOT_YET_RECRUITING NCT06232876 Continuous Versus Intermittent Ward Monitoring NOT_YET_RECRUITING NCT05673408 NIBP Validation Study RECRUITING NCT07599592 Open Label Study for the Use of Low Intensity Focused Ultrasound for Essential Tremor RECRUITING

Other Devices by Edan Instruments, Inc.

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 K152427PC ECG

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Related Devices (Code: MHX)

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 K152552Patient MonitorEdan Instruments, Inc.

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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