FDA 510(k) FDA class 2 Substantially Equivalent 🇨🇳 China

3MP GRAYSCAKE LCD DISPLAY

K Number: K140103 · Decision Feb 14, 2014
Classifications
1
FEI Numbers
609
Registration Numbers
609
Same Product Code
2221
Applicant Total
3
Review Days
30

Basic Information

Device Name
3MP GRAYSCAKE LCD DISPLAY
K Number
K140103
Device Class
FDA class 2
Clearance Type
Traditional
Regulation Number
892.2050
Medical Specialty
Radiology
Decision
Substantially Equivalent
Statement or Summary
Summary
Applicant
SHENZHEN BEACON DISPLAY TECHNOLOGY CO., LTD
Date Received
January 15, 2014
Decision Date
February 14, 2014
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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