MAC-LINE 02/CO2 NASAL CANNULA SAMPLE LINE

Analyzer, Gas, Carbon-dioxide, Gaseous-phase

ORIDION MEDICAL 1987 LTD.

The following data is part of a premarket notification filed by Oridion Medical 1987 Ltd. with the FDA for Mac-line 02/co2 Nasal Cannula Sample Line.

Pre-market Notification Details

Device IDK012395
510k NumberK012395
Device Name:MAC-LINE 02/CO2 NASAL CANNULA SAMPLE LINE
ClassificationAnalyzer, Gas, Carbon-dioxide, Gaseous-phase
Applicant ORIDION MEDICAL 1987 LTD. 7 HAMARPE ST. P.O. BOX 45025 HAR HOTZVIM INDUSTRIAL PARK Jerusalem,  IL 91450
ContactSanford Brown
CorrespondentSanford Brown
ORIDION MEDICAL 1987 LTD. 7 HAMARPE ST. P.O. BOX 45025 HAR HOTZVIM INDUSTRIAL PARK Jerusalem,  IL 91450
Product CodeCCK  
CFR Regulation Number868.1400 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeSpecial
3rd Party ReviewedNo
Combination ProductNo
Date Received2001-07-27
Decision Date2001-08-15
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
10884521552203 K012395 000
10884521640535 K012395 000
20884521551753 K012395 000

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