VITAL SIGNS MONITOR

Monitor, Physiological, Patient (without Arrhythmia Detection Or Alarms)

GUANGDONG BIOLIGHT MEDITECH CO., LTD

The following data is part of a premarket notification filed by Guangdong Biolight Meditech Co., Ltd with the FDA for Vital Signs Monitor.

Pre-market Notification Details

Device IDK113833
510k NumberK113833
Device Name:VITAL SIGNS MONITOR
ClassificationMonitor, Physiological, Patient (without Arrhythmia Detection Or Alarms)
Applicant GUANGDONG BIOLIGHT MEDITECH CO., LTD P.O. BOX 237-023 Shanghai,  CN 200237
ContactDiana Hong
CorrespondentDiana Hong
GUANGDONG BIOLIGHT MEDITECH CO., LTD P.O. BOX 237-023 Shanghai,  CN 200237
Product CodeMWI  
CFR Regulation Number870.2300 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2011-12-27
Decision Date2012-05-01
Summary:summary

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