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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 K170820
Device Name Capnograph and Oximeter
Applicant
CMI Health Inc.
5975 Shiloh Road, Suite 114
Alpharetta,  GA  30005
Applicant Contact Jiacheng Ren
Correspondent
International Regulatory Consulting
7808 Rush Creek Drive
Pasco,  WA  99301
Correspondent Contact Charles Mack
Regulation Number868.1400
Classification Product Code
CCK  
Subsequent Product Code
DQA  
Date Received03/20/2017
Decision Date 07/18/2018
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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