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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 K210019
Device Name Unimed CO2 Mainstream Module Model Capno-M, Unimed CO2 Mainstream Module Model Capno-M+
Applicant
Unimed Medical Supplies, Inc.
Bld#8, Nangang 3rd Industrial Park Tangtou, Shiyan
Shenzhen,  CN 518108
Applicant Contact Linbin Ye
Correspondent
Unimed Medical Supplies, Inc.
Bld#8, Nangang 3rd Industrial Park Tangtou, Shiyan
Shenzhen,  CN 518108
Correspondent Contact Linbin Ye
Regulation Number868.1400
Classification Product Code
CCK  
Date Received01/04/2021
Decision Date 03/04/2021
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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