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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Gas-Machine, Anesthesia
510(k) Number K253330
Device Name A5 Anesthesia System (A5); A7 Anesthesia System (A7)
Applicant
Shenzhen Mindray Bio-Medical Electronics Co., Ltd.
Mindray Bldg., Keji 12th Rd. S.
High-Tech Industrial Park, Nanshan
Shenzhen,  CN 518057
Applicant Contact Li Lei
Correspondent
Shenzhen Mindray Bio-Medical Electronics Co., Ltd.
Mindray Bldg., Keji 12th Rd. S.
High-Tech Industrial Park, Nanshan
Shenzhen,  CN 518057
Correspondent Contact Li Lei
Regulation Number868.5160
Classification Product Code
BSZ  
Subsequent Product Codes
CBQ   CBR   CBS   CCK   CCL  
KOI   NHO   NHP   NHQ   OLT   OLW  
OMC   ORT  
Date Received09/30/2025
Decision Date 06/25/2026
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Anesthesiology
510k Review Panel Anesthesiology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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