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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 K200594
Device Name Capnostream 35 Portable Respiratory Monitor
Applicant
Oridion Medical 1987 Ltd.
7 Hamarpe St.
Jerusalem,  IL 9777407
Applicant Contact Lital David
Correspondent
Hogan Lovells US LLP
555 13th St. NW
Washington, DC,  DC  20004
Correspondent Contact Jonathan Kahan
Regulation Number868.1400
Classification Product Code
CCK  
Subsequent Product Codes
DQA   MNR  
Date Received03/06/2020
Decision Date 04/27/2020
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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