FDA 510(k) Applications Submitted by ORIDION MEDICAL 1987 LTD.

FDA 510(k) Number Submission Date Device Name Applicant
K150272 02/04/2015 Capnostream 35 Portable Respiratory Monitor ORIDION MEDICAL 1987 LTD.
K181467 06/04/2018 Microstream Luer Adult-Pediatric Intubated Sampling Line, Microstream Advance Adult-Pediatric Intubated Filter Line Oridion Medical 1987 Ltd.
K181624 06/20/2018 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 Oridion Medical 1987 Ltd.
K121927 07/02/2012 MICROSTREAM FILTERLINE ICU ORIDION MEDICAL 1987 LTD.
K123690 12/03/2012 CAPNOSTREAM20P WITH HIFI C02 MONITORING ORIDION MEDICAL 1987 LTD.
K200594 03/06/2020 Capnostream 35 Portable Respiratory Monitor Oridion Medical 1987 Ltd.
K112368 08/17/2011 CAPNOSTREAM20P WITH AI/ODI ORIDION MEDICAL 1987 LTD.
K093388 10/30/2009 SMART CAPNOLINE GUARDIAN ORIDION MEDICAL 1987 LTD.
K011668 05/17/2001 VALIDATION OF THE BREATHID SYSTEM, FOR THE DETECTION OF HELICBACTOR PYLORI ORIDION MEDICAL 1987 LTD.
K042665 09/29/2004 SMART BITEBLOC ORIDION MEDICAL 1987 LTD.
K024300 12/24/2002 MICROCAP PLUS/NPB-75 ORIDION MEDICAL 1987 LTD.
K010024 01/03/2001 O2/CO2 NASAL FILTERLINE ORIDION MEDICAL 1987 LTD.
K011050 04/06/2001 MICROSTREAM ORAL NASAL CANNULA FILTERLINE ORIDION MEDICAL 1987 LTD.
K011536 05/18/2001 MICROSTREAM O2/CO2 ORAL NASAL FILTERLINE ORIDION MEDICAL 1987 LTD.
K002163 07/18/2000 MICROSTREAM EXTERNAL BATTERY CHARGER ORIDION MEDICAL 1987 LTD.
K012391 07/27/2001 MAC-LINE CO2 NASAL CANNULA SAMPLE LINE ORIDION MEDICAL 1987 LTD.
K012394 07/27/2001 ORIDION MAC-LINE ORAL NASAL CANNULA SAMPLE LINE ORIDION MEDICAL 1987 LTD.
K012395 07/27/2001 MAC-LINE 02/CO2 NASAL CANNULA SAMPLE LINE ORIDION MEDICAL 1987 LTD.
K013845 11/20/2001 MODIFICATION TO: MAC-LINE O2/CO2 ORAL NASAL CANNULA SAMPLE LINE ORIDION MEDICAL 1987 LTD.


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