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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 K181624
Device Name Microstream Advance Neonatal-Infant Nasal Filter Line with O2 Tubing, Microstream Advance Pediatric Oral-Nasal Filter Line with O2 Tubing, Microstream Advance Adult Oral-Nasal Filter Line with O2 Tubing, Microstream Luer Adult Oral-Nasal Sampling Line
Applicant
Oridion Medical 1987 , Ltd.
7 Hamarpe St., P.O. Box 45025
Jerusalem,  IL 9777407
Applicant Contact Dalia Givony
Correspondent
Oridion Medical 1987 , Ltd.
7 Hamarpe St., P.O. Box 45025
Jerusalem,  IL 9777407
Correspondent Contact Dalia Givony
Regulation Number868.1400
Classification Product Code
CCK  
Date Received06/20/2018
Decision Date 03/22/2019
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
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