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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name system, image processing, radiological
510(k) Number K052199
Device Name 21.3-INCH(54 CM) MONOCHROME LCD MONITOR MDL2115A (ME353I), (DV3MM-HB), (ME353IM)
Applicant
TOTOKU ELECTRIC CO., LTD
300 OYA
UEDA, NAGANO,  JP 386-0192
Applicant Contact MIKIO HASEGAWA
Correspondent
TOTOKU ELECTRIC CO., LTD
300 OYA
UEDA, NAGANO,  JP 386-0192
Correspondent Contact MIKIO HASEGAWA
Regulation Number892.2050
Classification Product Code
LLZ  
Date Received08/12/2005
Decision Date 09/22/2005
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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