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 K063863
Device Name ADVANTAGE CUFF, NON-INVASIVE BLOOD PRESSURE HOSE AND ADAPTER
Applicant
Advantage Medical Cables, Inc.
10630 Wiles Rd.
Coral Springs,  FL  33076
Applicant Contact KEN KENDRICKS
Correspondent
Advantage Medical Cables, Inc.
10630 Wiles Rd.
Coral Springs,  FL  33076
Correspondent Contact KEN KENDRICKS
Regulation Number870.1120
Classification Product Code
DXQ  
Date Received12/28/2006
Decision Date 03/20/2007
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
-
-