21.3 INCH (53CM) MONOCHROME DIGITAL MAMMOGRAPHY LCD MONITOR MS51I2, (MDL2123A)


Device Classification Name

system, image processing, radiological

510(k) Number K081242
Device Name 21.3 INCH (53CM) MONOCHROME DIGITAL MAMMOGRAPHY LCD MONITOR MS51I2, (MDL2123A)
Applicant
TOKOTU ELECTRIC CO., LTD.
300 oya, ueda
nagano, 

JP

386-0192

Applicant Contact mikio hasegawa
Correspondent
TOKOTU ELECTRIC CO., LTD.
300 oya, ueda
nagano, 

JP

386-0192

Correspodent Contact mikio hasegawa
Regulation Number 892.2050
Classification Product Code
LLZ  
Date Received 05/01/2008
Decision Date 06/11/2008
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Radiology

510k Review Panel

Radiology

summary

summary

Type Traditional
Reviewed by Third Party No

Combination Product

No