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 Stimulator, Electro-Acupuncture
510(k) Number K140788
Device Name P-STIM
Applicant
BIEGLER GMBH
24301 WOODSAGE DR
BONITA SPRINGS,  FL  34134
Applicant Contact PAUL DRYDEN
Correspondent
BIEGLER GMBH
24301 WOODSAGE DR
BONITA SPRINGS,  FL  34134
Correspondent Contact PAUL DRYDEN
Classification Product Code
BWK  
Date Received03/31/2014
Decision Date 06/27/2014
Decision Substantially Equivalent (SESE)
510k Review Panel Neurology
Statement Statement
Type Traditional
Reviewed by Third Party No
Combination Product No
-
-