FLEXICOIL - MALLEABLE RECEIVE-ONLY SURFACE COIL

Coil, Magnetic Resonance, Specialty

ODIN MEDICAL TECHNOLOGIES LTD.

The following data is part of a premarket notification filed by Odin Medical Technologies Ltd. with the FDA for Flexicoil - Malleable Receive-only Surface Coil.

Pre-market Notification Details

Device IDK020601
510k NumberK020601
Device Name:FLEXICOIL - MALLEABLE RECEIVE-ONLY SURFACE COIL
ClassificationCoil, Magnetic Resonance, Specialty
Applicant ODIN MEDICAL TECHNOLOGIES LTD. P.O. BOX 248 Yokneam Elit,  IL 20692
ContactAdi Ickowicz
CorrespondentAdi Ickowicz
ODIN MEDICAL TECHNOLOGIES LTD. P.O. BOX 248 Yokneam Elit,  IL 20692
Product CodeMOS  
CFR Regulation Number892.1000 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2002-02-22
Decision Date2002-04-24
Summary:summary

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