Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR) 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 the device name listed in this FDA 510(k) record. The listed applicant is Guangdong Biolight Meditech Co., Ltd.. It received FDA 510(k) clearance on 2017-01-04 under 510(k) 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. The listed applicant is Guangdong Biolight Meditech Co., Ltd.. The 510(k) number is K162234.

When did Truscope Ultra Patient Monitor receive FDA 510(k) clearance?

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

Who is the listed applicant for Truscope Ultra Patient Monitor?

The FDA 510(k) record lists Guangdong Biolight Meditech Co., Ltd. as the applicant. This does not by itself establish the device manufacturer.

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

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

Other records listing Guangdong Biolight Meditech Co., Ltd. as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K181919Patient MonitorK170514Central Monitoring SystemK160349Electronic SphygmomanometerK153580Central Monitoring SystemK153135VITAL SIGNS MONITORK152739Electronic Thermometer

View all 8 devices →

Related Devices (Code: MWI)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K260438Vital Signs Monitor (CLEO2)Infinium Medical, Inc.K253417Masimo Root Monitoring SystemMasimo CorporationK253196Midmark 800 Digital Vital Signs Device (1-300-0100, 1-300-0200, 1-300-0300, 1-300-0400)Midmark CorporationK253436c-med0 alphaCosinuss GmbHK250135WAVE Clinical Platform (2.0.000)Baxter Healthcare Corp/ Excel MedicalK241766QMAPP® (Hemo, Hemo Lite, PCM, GO, Hybrid)Fysicon BV

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.

↑