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, Nerve, Battery-Powered
510(k) Number K111985
Device Name MYOGUIDE SYSTEM MODEL 8008
Applicant
INTRONIX TECHNOLOGIES CORP.
611 WEST 5TH STREET
AUSTIN,  TX  78701
Applicant Contact RICHARD VINCINS, CQA, RAC (US,EU)
Correspondent
INTRONIX TECHNOLOGIES CORP.
611 WEST 5TH STREET
AUSTIN,  TX  78701
Correspondent Contact RICHARD VINCINS, CQA, RAC (US,EU)
Regulation Number868.2775
Classification Product Code
BXN  
Date Received07/12/2011
Decision Date 12/30/2011
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Anesthesiology
510k Review Panel Anesthesiology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
-
-