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, Muscle, Powered
510(k) Number K945509
Device Name FX-2 NMS (2CHANNEL TABLE MODEL)
Applicant
Fx-2
616 Vineyard Pt.
Guilford,  CT  06437
Applicant Contact MARK HELLER
Correspondent
Fx-2
616 Vineyard Pt.
Guilford,  CT  06437
Correspondent Contact MARK HELLER
Regulation Number890.5850
Classification Product Code
IPF  
Date Received11/09/1994
Decision Date 05/02/1995
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Physical Medicine
510k Review Panel Physical Medicine
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
-
-