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FDA 510(k)

Telemetry Transmitter

K-Number: K161056 · 2017-02-03

ApplicantEdan Instruments, Inc.
Decision Date2017-02-03
Product CodeMHX
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

Telemetry Transmitter is a medical device manufactured by Edan Instruments, Inc.. It received FDA 510(k) clearance on 2017-02-03 under approval number K161056. 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 Telemetry Transmitter?

Telemetry Transmitter is a medical device that received FDA 510(k) clearance on 2017-02-03. It is manufactured by Edan Instruments, Inc.. The 510(k) number is K161056.

When was Telemetry Transmitter approved by the FDA?

Telemetry Transmitter received FDA 510(k) clearance on 2017-02-03, under approval number K161056.

What company makes Telemetry Transmitter?

Telemetry Transmitter is manufactured by Edan Instruments, Inc..

What is the FDA product code for Telemetry Transmitter?

The FDA product code for Telemetry Transmitter is MHX.

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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