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 K222208
Device Name Hisense LCD monitor HMD2C21A, HMD4C27S, HMD6C30D
Applicant
Qingdao Hisense Medical Equipment Co., Ltd.
# 399 Songling Rd., Laoshan District
266100, Qingdao, Shandong, P. R. China
Qingdao,  CN 266100
Applicant Contact Lu Zhonghao
Correspondent
Qingdao Hisense Medical Equipment Co., Ltd.
# 399 Songling Rd., Laoshan District
266100, Qingdao, Shandong, P. R. China
Qingdao,  CN 266100
Correspondent Contact Lu Zhonghao
Regulation Number892.2050
Classification Product Code
PGY  
Date Received07/25/2022
Decision Date 11/17/2022
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
-
-