SONOVIEW PRO BY MEDISON CO., LTD.

System, Image Processing, Radiological

MEDISON CO., LTD.

The following data is part of a premarket notification filed by Medison Co., Ltd. with the FDA for Sonoview Pro By Medison Co., Ltd..

Pre-market Notification Details

Device IDK031886
510k NumberK031886
Device Name:SONOVIEW PRO BY MEDISON CO., LTD.
ClassificationSystem, Image Processing, Radiological
Applicant MEDISON CO., LTD. 1100 LAKEVIEW BLVD. Denton,  TX  76208
ContactCarl Alletto
CorrespondentNed Devine
ENTELA, INC. 3033 MADISON AVENUE, SE Grand Rapids,  MI  49548
Product CodeLLZ  
CFR Regulation Number892.2050 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedYes
Combination ProductNo
Date Received2003-06-18
Decision Date2003-06-30
Summary:summary

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