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FDA 510(k)

Surveyor S4 Mobile Monitor

K-Number: K160685 · 2016-08-04

ApplicantMortara Instrument, Inc.
Decision Date2016-08-04
Product CodeMHX
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

Surveyor S4 Mobile Monitor is a medical device manufactured by Mortara Instrument, Inc.. It received FDA 510(k) clearance on 2016-08-04 under approval number K160685. 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 Surveyor S4 Mobile Monitor?

Surveyor S4 Mobile Monitor is a medical device that received FDA 510(k) clearance on 2016-08-04. It is manufactured by Mortara Instrument, Inc.. The 510(k) number is K160685.

When was Surveyor S4 Mobile Monitor approved by the FDA?

Surveyor S4 Mobile Monitor received FDA 510(k) clearance on 2016-08-04, under approval number K160685.

What company makes Surveyor S4 Mobile Monitor?

Surveyor S4 Mobile Monitor is manufactured by Mortara Instrument, Inc..

What is the FDA product code for Surveyor S4 Mobile Monitor?

The FDA product code for Surveyor S4 Mobile Monitor is MHX.

Related Clinical Trials

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Other Devices by Mortara Instrument, Inc.

K161465CardioConfirm K152626H3+ Holter Recorder K152944Xscribe Stress Exercise Testing Systems, Q-Stress Stress Exercise Testing Systems K161517Mortara Surveyor Patient Monitor K173765Surveyor Patient Monitor K182297Surveyor S2

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Related Devices (Code: MHX)

K160981Patient MonitorEdan Instruments, Inc. K153707Nihon Kohden Vital Sign TelemeterNihon Kohden Corporation 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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