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FDA 510(k)

Masimo Root Vital Signs Monitoring System and Accessories

K-Number: K151644 · 2016-02-12

ApplicantMasimo Corporation
Decision Date2016-02-12
Product CodeMWI
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

Masimo Root Vital Signs Monitoring System and Accessories is a medical device manufactured by Masimo Corporation. It received FDA 510(k) clearance on 2016-02-12 under approval number K151644. The device is classified under product code MWI. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Masimo Root Vital Signs Monitoring System and Accessories?

Masimo Root Vital Signs Monitoring System and Accessories is a medical device that received FDA 510(k) clearance on 2016-02-12. It is manufactured by Masimo Corporation. The 510(k) number is K151644.

When was Masimo Root Vital Signs Monitoring System and Accessories approved by the FDA?

Masimo Root Vital Signs Monitoring System and Accessories received FDA 510(k) clearance on 2016-02-12, under approval number K151644.

What company makes Masimo Root Vital Signs Monitoring System and Accessories?

Masimo Root Vital Signs Monitoring System and Accessories is manufactured by Masimo Corporation.

What is the FDA product code for Masimo Root Vital Signs Monitoring System and Accessories?

The FDA product code for Masimo Root Vital Signs Monitoring System and Accessories is MWI.

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Related PubMed Literature

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Other Devices by Masimo Corporation

K162675Masimo Rainbow SET Intellivue Module Pulse CO-Oximeter K160940Masimo Disposable Transflectance Forehead Sensor K153225Masimo Root Monitoring System and Accessories K160526Masimo O3 Regional Oximeter System K171121Masimo Root Monitoring System and Accessories K170168Masimo Rad-97 and Accessories

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Related Devices (Code: MWI)

K161909IQvitals ZoneMidmark Corporation K160718Vital Sync Informatics Manager & Virtual Patient Monitoring PlatformCovidien K151839AMC Health VitalCaregiving SystemAmc Health K160956LD-Oxi systemLd Technology, LLC K153739MRI Patient Monitor TeslaDUOMipm Mammendorfer Institut Fur Physik Und Medizin K153225Masimo Root Monitoring System and AccessoriesMasimo Corporation

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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