PRESTODR PORTABLE

System, X-ray, Mobile

CMT MEDICAL TECHNOLOGIES, LTD.

The following data is part of a premarket notification filed by Cmt Medical Technologies, Ltd. with the FDA for Prestodr Portable.

Pre-market Notification Details

Device IDK100400
510k NumberK100400
Device Name:PRESTODR PORTABLE
ClassificationSystem, X-ray, Mobile
Applicant CMT MEDICAL TECHNOLOGIES, LTD. HACARMEL ST BUILDING 7/2 P.O.B. 111 Yoqneam Ilit,  IL 20692
ContactShlomi Dines
CorrespondentShlomi Dines
CMT MEDICAL TECHNOLOGIES, LTD. HACARMEL ST BUILDING 7/2 P.O.B. 111 Yoqneam Ilit,  IL 20692
Product CodeIZL  
CFR Regulation Number892.1720 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeSpecial
3rd Party ReviewedNo
Combination ProductNo
Date Received2010-02-16
Decision Date2010-04-22
Summary:summary

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