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FDA 510(k) Application Details - K190848
Device Classification Name
More FDA Info for this Device
510(K) Number
K190848
Device Name
JUSHA-M550G/ JUSHA-M550/M550G/M550 LCD Monitor
Applicant
Nanjing Jusha Display Technology Co., Ltd
Suite A, 8/F, Bldg 1, No. 301, Hanzhongmen St.
Nanjing 210036 CN
Other 510(k) Applications for this Company
Contact
Zilong Liang
Other 510(k) Applications for this Contact
Regulation Number
More FDA Info for this Regulation Number
Classification Product Code
PGY
Other 510(k) Applications for this Device
More FDA Info for this Product Code
Date Received
04/01/2019
Decision Date
05/14/2019
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
RA - Radiology
Review Advisory Committee
RA - Radiology
Statement / Summary / Purged Status
Summary
Type
Traditional
Reviewed By Third Party
N
Expedited Review
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