• 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, neuromuscular, external functional
510(k) Number K173682
Device Name L300 Go System
Applicant
Bioness, Inc.
25103 Rye Canyon Loop
valencia,  CA  91355
Applicant Contact mercedes bayani
Correspondent
Bioness, Inc.
25103 Rye Canyon Loop
valencia,  CA  91355
Correspondent Contact mary dadone
Regulation Number882.5810
Classification Product Code
GZI  
Subsequent Product Code
IPF  
Date Received12/01/2017
Decision Date 03/09/2018
Decision substantially equivalent (SESE)
Regulation Medical Specialty Neurology
510k Review Panel Neurology
summary summary
Type Traditional
Reviewed by Third Party No
Combination Product No
-
-