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 K192925
Device Name 32HL512D
Applicant
Lg Electronics.Inc
222, Lg-Ro, Cheongho-Ri, Jinwi-Myeon
Pyeongtaek-Si,  KR 17709
Applicant Contact Jinhwan Jun
Correspondent
Lg Electronics.Inc
222, Lg-Ro, Cheongho-Ri, Jinwi-Myeon
Pyeongtaek-Si,  KR 17709
Correspondent Contact Jinhwan Jun
Regulation Number892.2050
Classification Product Code
PGY  
Subsequent Product Code
LLZ  
Date Received10/16/2019
Decision Date 03/13/2020
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
-
-