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510(k) K182821

Device
Accutorr 7/VS-900/VS-900c Vital Signs Monitor
Applicant
Shenzhen Mindray Bio-medical Electronics Co., LTD.
510(k) number
K182821
Product code
MWI  
Decision
Substantially Equivalent (SESE)
Decision date
2019-03-27
Date received
2018-10-04
Regulation
870.2300
Classification name
Monitor, Physiological, Patient (without Arrhythmia Detection Or Alarms)
Medical specialty
Cardiovascular
Review panel
Cardiovascular
Device class
2
Clearance type
Special
Statement or summary
Summary
Third party reviewed
No

Applicant Contact#

Contact
Yanhong Bai
Address
Hi-Tech Industrial Park, Nanshan Shenzhen CN 518057 518057

FDA Registration Numbers#

Source Documents#

510(k) summary PDF

Other 510(k) Records For Product Code MWI  #

510(k), Device, Applicant table
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K234130Portrait™ Mobile Monitoring Solution consists of: • Portrait™ Central Viewer Application (Portrait CVAXB) • Portrait™ Core Services (Portrait CSSXB) • Portrait™ Clinical Alarming Unit (Portrait CAU01) • Portrait™ Mobile Patient Monitor Hardware (Portrait HUBXB) • Portrait™ Mobile Patient Monitor Software (Portrait HSWXB) • Portrait™ Wearable Pulse Oximetry Sensor (Portrait SpO2 P-SA01) • Portrait™ Wearable Pulse Oximetry Sensor (Portrait SpO2 P-SP01) • Portrait™ Wearable Pulse OGe Medical Systems Information Technologies, Inc.2024-03-20