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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Ventilator, Continuous, Facility Use
510(k) Number K220107
Device Name Mindray SV600 Ventilator, Mindray SV800 Ventilator
Applicant
Shenzhen Mindray Bio-medical Electronics Co.,LTD.
Mindray Building, Keji 12th Road South,
Hi-tech Industrial Park, Nanshan
Shenzhen,  CN 518057
Applicant Contact Yanhong Bai
Correspondent
Shenzhen Mindray Bio-medical Electronics Co.,LTD.
Mindray Building, Keji 12th Road South,
Hi-tech Industrial Park, Nanshan
Shenzhen,  CN 518057
Correspondent Contact Yanhong Bai
Regulation Number868.5895
Classification Product Code
CBK  
Date Received01/12/2022
Decision Date 06/16/2023
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Anesthesiology
510k Review Panel Anesthesiology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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