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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Analyzer, Gas, Carbon-Dioxide, Gaseous-Phase
510(k) Number K250148
Device Name Medical Gas Analyzer (AG200)
Applicant
Prior Care Science Technology, Ltd.
Area F2 ,2f, Bldg. 1, Bao'An Ave. Industrial Zone,
Yabian Xueziwei, Yabian Community, Shajing Subdictrict, Bao'
Shenzhen,  CN 518101
Applicant Contact John Liu
Correspondent
Prior Care Science Technology, Ltd.
Area F2 ,2f, Bldg. 1, Bao'An Ave. Industrial Zone,
Yabian Xueziwei, Yabian Community, Shajing Subdictrict, Bao'
Shenzhen,  CN 518101
Correspondent Contact John Liu
Regulation Number868.1400
Classification Product Code
CCK  
Subsequent Product Codes
CBQ   CBR   CBS   NHO   NHP  
NHQ  
Date Received01/21/2025
Decision Date 08/28/2025
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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