FDA 510(k) FDA class 2 Substantially Equivalent 🇯🇵 Japan

20.1-INCH (51CM) COLOR LCD MONITOR CDL2009A (CCL204)

K Number: K061061 · Decision Jun 7, 2006
Classifications
1
FEI Numbers
609
Registration Numbers
609
Same Product Code
2221
Applicant Total
2
Review Days
51

Basic Information

Device Name
20.1-INCH (51CM) COLOR LCD MONITOR CDL2009A (CCL204)
K Number
K061061
Device Class
FDA class 2
Clearance Type
Traditional
Regulation Number
892.2050
Medical Specialty
Radiology
Decision
Substantially Equivalent
Statement or Summary
Summary
Applicant
TOKOTU ELECTRIC CO., LTD.
Date Received
April 17, 2006
Decision Date
June 7, 2006
Product Code
LLZ
Advisory Committee
Radiology
Review Advisory Committee
RA
Third Party
N

Classifications

This FDA 510(k) entry is associated with 1 FDA classification via its product code.

Product Code Device Name
LLZ System, Image Processing, Radiological

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K Number Device Name
K081242 21.3 INCH (53CM) MONOCHROME DIGITAL MAMMOGRAPHY LCD MONITOR MS51I2, (MDL2123A)