Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links
  • Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

510(k) Premarket Notification
  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 


New Search Back To Search Results
Device Classification Name Display, Diagnostic Radiology
510(k) Number K201599
Device Name 2MP Color/Monochrome LCD Monitors C22S+, C22SP+/G22S+, G22SP+, G23S+, G23SP+
Applicant
Shenzhen Beacon Display Technology Co., Ltd.
12f, Block Bl, Nanshanzhiyuan, #1001 Xueyuan Rd.
Shenzhen,  CN 518055
Applicant Contact Fu Ailing
Correspondent
Shenzhen Beacon Display Technology Co., Ltd.
12f, Block Bl, Nanshanzhiyuan, #1001 Xueyuan Rd.
Shenzhen,  CN 518055
Correspondent Contact Fu Ailing
Regulation Number892.2050
Classification Product Code
PGY  
Date Received06/12/2020
Decision Date 07/02/2020
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
-
-