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 K132137
Device Name MULTISTIM
Applicant
Metron Medical Australia, Pty, Ltd.
57 Aster Ave.
Carrum Downs,  AU 3201
Applicant Contact DAVID MITCHELL
Correspondent
Metron Medical Australia, Pty, Ltd.
57 Aster Ave.
Carrum Downs,  AU 3201
Correspondent Contact DAVID MITCHELL
Regulation Number890.5850
Classification Product Code
IPF  
Subsequent Product Codes
GZJ   LIH  
Date Received07/11/2013
Decision Date 09/12/2013
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Physical Medicine
510k Review Panel Physical Medicine
Statement Statement
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
-
-