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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 K150272
Device Name Capnostream 35 Portable Respiratory Monitor
Applicant
ORIDION MEDICAL 1987 LTD.
7 HAMARPE ST.
JERUSALEM,  IL 9777407
Applicant Contact Dalia Givony
Correspondent
ORIDION MEDICAL 1987 LTD.
7 HAMARPE ST.
JERUSALEM,  IL 9777407
Correspondent Contact Dalia Givony
Regulation Number868.1400
Classification Product Code
CCK  
Subsequent Product Codes
DQA   MNR  
Date Received02/04/2015
Decision Date 07/17/2015
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
Recalls CDRH Recalls
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