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FDA 510(k)

Mortara Surveyor Patient Monitor

K-Number: K161517 · 2017-01-11

ApplicantMortara Instrument, Inc.
Decision Date2017-01-11
Product CodeMHX
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

Mortara Surveyor Patient Monitor is a medical device manufactured by Mortara Instrument, Inc.. It received FDA 510(k) clearance on 2017-01-11 under approval number K161517. 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 Mortara Surveyor Patient Monitor?

Mortara Surveyor Patient Monitor is a medical device that received FDA 510(k) clearance on 2017-01-11. It is manufactured by Mortara Instrument, Inc.. The 510(k) number is K161517.

When was Mortara Surveyor Patient Monitor approved by the FDA?

Mortara Surveyor Patient Monitor received FDA 510(k) clearance on 2017-01-11, under approval number K161517.

What company makes Mortara Surveyor Patient Monitor?

Mortara Surveyor Patient Monitor is manufactured by Mortara Instrument, Inc..

What is the FDA product code for Mortara Surveyor Patient Monitor?

The FDA product code for Mortara Surveyor Patient Monitor is MHX.

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Other Devices by Mortara Instrument, Inc.

K161465CardioConfirm K160685Surveyor S4 Mobile Monitor K152626H3+ Holter Recorder K152944Xscribe Stress Exercise Testing Systems, Q-Stress Stress Exercise Testing Systems K173765Surveyor Patient Monitor K182297Surveyor S2

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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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