SMART BITEBLOC

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 Smart Bitebloc.

Pre-market Notification Details

Device IDK042665
510k NumberK042665
Device Name:SMART BITEBLOC
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
ContactSandy Brown
CorrespondentSandy 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)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2004-09-29
Decision Date2004-11-23
Summary:summary

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