3M COLOR MEDICAL FLAT PANEL DISPLAY, CCL316

System, Image Processing, Radiological

TOTOKU ELECTRIC CO., LTD

The following data is part of a premarket notification filed by Totoku Electric Co., Ltd with the FDA for 3m Color Medical Flat Panel Display, Ccl316.

Pre-market Notification Details

Device IDK032555
510k NumberK032555
Device Name:3M COLOR MEDICAL FLAT PANEL DISPLAY, CCL316
ClassificationSystem, Image Processing, Radiological
Applicant TOTOKU ELECTRIC CO., LTD 300 OYA , UEDA-SHI, Nagano-ken,  JP 386-0192
ContactMikio Hasegawa
CorrespondentMikio Hasegawa
TOTOKU ELECTRIC CO., LTD 300 OYA , UEDA-SHI, Nagano-ken,  JP 386-0192
Product CodeLLZ  
CFR Regulation Number892.2050 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2003-08-19
Decision Date2004-02-26

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