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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
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