MICROCAP PLUS/NPB-75

Oximeter

ORIDION MEDICAL 1987 LTD.

The following data is part of a premarket notification filed by Oridion Medical 1987 Ltd. with the FDA for Microcap Plus/npb-75.

Pre-market Notification Details

Device IDK024300
510k NumberK024300
Device Name:MICROCAP PLUS/NPB-75
ClassificationOximeter
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 CodeDQA  
CFR Regulation Number870.2700 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeSpecial
3rd Party ReviewedNo
Combination ProductNo
Date Received2002-12-24
Decision Date2003-04-03
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
10884521582507 K024300 000
10884521582545 K024300 000
10884521520790 K024300 000

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