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 Lin

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 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 Lin.

Pre-market Notification Details

Device IDK181624
510k NumberK181624
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 Lin
ClassificationAnalyzer, Gas, Carbon-dioxide, Gaseous-phase
Applicant Oridion Medical 1987 Ltd. 7 Hamarpe Street, P.O. Box 45025 Jerusalem,  IL 9777407
ContactDalia Givony
CorrespondentDalia Givony
Oridion Medical 1987 Ltd. 7 Hamarpe Street, P.O. Box 45025 Jerusalem,  IL 9777407
Product CodeCCK  
CFR Regulation Number868.1400 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2018-06-20
Decision Date2019-03-22
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
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20884838093793 K181624 000
20884838093762 K181624 000
20884838091782 K181624 000

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