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FDA 510(k)

Patient Monitor

K-Number: K181919 · 2019-04-05

ApplicantGuangdong Biolight Meditech Co., Ltd.
Decision Date2019-04-05
Product CodeMWI
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

Patient Monitor is a medical device manufactured by Guangdong Biolight Meditech Co., Ltd.. It received FDA 510(k) clearance on 2019-04-05 under approval number K181919. 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 Patient Monitor?

Patient Monitor is a medical device that received FDA 510(k) clearance on 2019-04-05. It is manufactured by Guangdong Biolight Meditech Co., Ltd.. The 510(k) number is K181919.

When was Patient Monitor approved by the FDA?

Patient Monitor received FDA 510(k) clearance on 2019-04-05, under approval number K181919.

What company makes Patient Monitor?

Patient Monitor is manufactured by Guangdong Biolight Meditech Co., Ltd..

What is the FDA product code for Patient Monitor?

The FDA product code for Patient Monitor is MWI.

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Other Devices by Guangdong Biolight Meditech Co., Ltd.

K160349Electronic Sphygmomanometer K153580Central Monitoring System K153135VITAL SIGNS MONITOR K152739Electronic Thermometer K151287Fingertip Pulse Oximeters M70, M70A, M70B, M70C, M70D K170514Central Monitoring System

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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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