FDA 510(k) Application Details - K200864

Device Classification Name

  More FDA Info for this Device
510(K) Number K200864
Device Name 5MP Color LCD Monitors C53S+, C53SP+, 5MP Monochrome LCD Monitors G53S+, G53SP+
Applicant Shenzhen Beacon Display Technology Co., Ltd.
12F, Block B1, Nanshan Zhiyuan, No.1001 Xueyuan Road
Shenzhen 518055 CN
Other 510(k) Applications for this Company
Contact Fu Ailing
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 04/01/2020
Decision Date 05/19/2020
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



Search | Companies | Product Codes | Device Names | Contacts | Applications | Decisions | Contact