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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name monitor, physiological, patient (without arrhythmia detection or alarms)
510(k) Number K221113
Device Name Accutorr 3 Vital Signs Monitor, Rosebud Vital Signs Monitor
Applicant
Shenzhen Mindray Bio-Medical Electronics Co., LTD
Mindray Building, Keji 12th Road South
Hi-tech Industrial Park, Nanshan
Shenzhen,  CN 518057
Applicant Contact Li Lei
Correspondent
Shenzhen Mindray Bio-Medical Electronics Co., LTD
Mindray Building, Keji 12th Road South
Hi-tech Industrial Park, Nanshan
Shenzhen,  CN 518057
Correspondent Contact Li Lei
Regulation Number870.2300
Classification Product Code
MWI  
Date Received04/15/2022
Decision Date 12/02/2022
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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