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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
Recalls CDRH Recalls
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