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 K853750
Device Name SYS*STIM 207 MODEL ME 207
Applicant
Mettler Electronics Corp.
1333 S. Claudina St.
Anaheim,  CA  92805
Applicant Contact ROB FLEMING
Correspondent
Mettler Electronics Corp.
1333 S. Claudina St.
Anaheim,  CA  92805
Correspondent Contact ROB FLEMING
Regulation Number890.5850
Classification Product Code
IPF  
Date Received09/09/1985
Decision Date 11/26/1985
Decision SUBSTANTIALLY EQUIVALENT FOR SOME INDICATIONS (SN)
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
-
-