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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 Street, P.O. Box 45025
Jerusalem,  IL 9777407
Applicant Contact Dalia Givony
Correspondent
Oridion Medical 1987 Ltd.
7 Hamarpe Street, 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
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