21.3-INCH(54 CM) MONOCHROME LCD MONITOR MDL2115A (ME353I), (DV3MM-HB), (ME353IM)

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 21.3-inch(54 Cm) Monochrome Lcd Monitor Mdl2115a (me353i), (dv3mm-hb), (me353im).

Pre-market Notification Details

Device IDK052199
510k NumberK052199
Device Name:21.3-INCH(54 CM) MONOCHROME LCD MONITOR MDL2115A (ME353I), (DV3MM-HB), (ME353IM)
ClassificationSystem, Image Processing, Radiological
Applicant TOTOKU ELECTRIC CO., LTD 300 OYA Ueda, Nagano,  JP 386-0192
ContactMikio Hasegawa
CorrespondentMikio Hasegawa
TOTOKU ELECTRIC CO., LTD 300 OYA Ueda, Nagano,  JP 386-0192
Product CodeLLZ  
CFR Regulation Number892.2050 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2005-08-12
Decision Date2005-09-22
Summary:summary

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