Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR, NMPA) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

FDA 510(k)

Truscope Ultra Patient Monitor

K-Number: K162234 · 2017-01-04

ApplicantGuangdong Biolight Meditech Co., Ltd.
Decision Date2017-01-04
Product CodeMWI
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

Truscope Ultra Patient Monitor is a medical device manufactured by Guangdong Biolight Meditech Co., Ltd.. It received FDA 510(k) clearance on 2017-01-04 under approval number K162234. 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 Truscope Ultra Patient Monitor?

Truscope Ultra Patient Monitor is a medical device that received FDA 510(k) clearance on 2017-01-04. It is manufactured by Guangdong Biolight Meditech Co., Ltd.. The 510(k) number is K162234.

When was Truscope Ultra Patient Monitor approved by the FDA?

Truscope Ultra Patient Monitor received FDA 510(k) clearance on 2017-01-04, under approval number K162234.

What company makes Truscope Ultra Patient Monitor?

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

What is the FDA product code for Truscope Ultra Patient Monitor?

The FDA product code for Truscope Ultra Patient Monitor is MWI.

Related Clinical Trials

NCT07614139 Continuous Glucose Monitoring Alerts, Accuracy, and Patient Outcomes in Adults With Inherited Metabolic Disorders COMPLETED NCT07301385 Evaluation of Head-Mounted Spatial Computing and Three-Dimensional (3D) Visualization in Ocular Microsurgery: A Safety and Workflow Study ACTIVE_NOT_RECRUITING NCT07606495 Impact on Prognosis of Increased Sleep Quality Obtained by Personalized Night-time Nursing Care in Critically Ill Patients NOT_YET_RECRUITING NCT06232876 Continuous Versus Intermittent Ward Monitoring NOT_YET_RECRUITING NCT05673408 NIBP Validation Study RECRUITING NCT07599592 Open Label Study for the Use of Low Intensity Focused Ultrasound for Essential Tremor RECRUITING

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

View all 8 devices →

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.

↑