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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name System, Nuclear Magnetic Resonance Imaging
510(k) Number K991243
Device Name NORMA 10
Applicant
ODIN TECHNOLOGIES LTD.
P.O. BOX 248
YOKNEAM ELIT,  IL 20698
Applicant Contact ADI ICKOWICZ
Correspondent
ODIN TECHNOLOGIES LTD.
P.O. BOX 248
YOKNEAM ELIT,  IL 20698
Correspondent Contact ADI ICKOWICZ
Regulation Number892.1000
Classification Product Code
LNH  
Date Received04/12/1999
Decision Date 06/18/1999
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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