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 Pad, Heating, Powered
510(k) Number K133981
Device Name AVACEN 100
Applicant
AVACEN INC.
7920 SILVERTON AVENUE
SUITE L
SAN DIEGO,  CA  92126
Applicant Contact THOMAS G MUEHLABUER
Correspondent
AVACEN INC.
7920 SILVERTON AVENUE
SUITE L
SAN DIEGO,  CA  92126
Correspondent Contact THOMAS G MUEHLABUER
Regulation Number890.5740
Classification Product Code
IRT  
Date Received12/26/2013
Decision Date 08/15/2014
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Physical Medicine
510k Review Panel Physical Medicine
Summary Summary
Type Abbreviated
Clinical Trials NCT01619579
Reviewed by Third Party No
Combination Product No
-
-