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 K120364
Device Name UNIMED DISPOSABLE BLOOD PRESSURE CUFF
Applicant
UNIMED MEDICAL SUPPLIES INC.
NO.37, YANSHAN ROAD, SHEKOU
SHENZHEN, GUANGDONG,  CN 518067
Applicant Contact XINMEI TAN
Correspondent
UNIMED MEDICAL SUPPLIES INC.
NO.37, YANSHAN ROAD, SHEKOU
SHENZHEN, GUANGDONG,  CN 518067
Correspondent Contact XINMEI TAN
Regulation Number870.1120
Classification Product Code
DXQ  
Date Received02/06/2012
Decision Date 05/04/2012
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
-
-