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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 K123690
Device Name CAPNOSTREAM20P WITH HIFI C02 MONITORING
Applicant
ORIDION MEDICAL 1987 LTD.
7 HAMARPE ST.
HAR HOTZVIM INDUSTRIAL PARK
JERUSALEM,  IL 91450
Applicant Contact DALIA GIVONY
Correspondent
ORIDION MEDICAL 1987 LTD.
7 HAMARPE ST.
HAR HOTZVIM INDUSTRIAL PARK
JERUSALEM,  IL 91450
Correspondent Contact DALIA GIVONY
Regulation Number868.1400
Classification Product Code
CCK  
Subsequent Product Codes
DQA   MNR  
Date Received12/03/2012
Decision Date 08/05/2014
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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