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 Blood Pressure Cuff
510(k) Number K191209
Device Name Aneroid Type Blood Pressure Kit
Applicant
Dongguan Mars Medical Products Co., Ltd.
381, Manfeng W. Rd., Manfeng Group
Dani Village, Shatian Town, Dongguan Cit,  CN 523993
Applicant Contact Lily Liao
Correspondent
Guangzhou Junyi Information Technology Co., Ltd.
Rm. 215, Huaming Bldg., Chebei Rd.
Guangzhou,  CN 511660
Correspondent Contact Jinghua Zhou
Regulation Number870.1120
Classification Product Code
DXQ  
Date Received05/06/2019
Decision Date 06/18/2019
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
-
-