CDP 5000, MEDIA AND DISTRIBUTION CENTER, DIAGNET

System, Image Processing, Radiological

CDP, LTD.

The following data is part of a premarket notification filed by Cdp, Ltd. with the FDA for Cdp 5000, Media And Distribution Center, Diagnet.

Pre-market Notification Details

Device IDK072960
510k NumberK072960
Device Name:CDP 5000, MEDIA AND DISTRIBUTION CENTER, DIAGNET
ClassificationSystem, Image Processing, Radiological
Applicant CDP, LTD. 23 EFAL STREET P.O. BOX 3325 Kiriat Arie, Petach Tikva,  IL 49130
ContactDoron David
CorrespondentHarry Van Vugt
KEMA QUALITY B.V. 4377 COUNTY LINE ROAD Chalfont,  PA  18914
Product CodeLLZ  
CFR Regulation Number892.2050 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedYes
Combination ProductNo
Date Received2007-10-19
Decision Date2007-11-08
Summary:summary

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