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 device, biofeedback
510(k) Number K071661
Device Name ALPHAONE BIOFEEDBACK SYSTEM
Applicant
TELEDIAGNOSTIC SYSTEMS, INC.
2484 OLD MIDDLEFIELD WAY
SUITE 202
MOUNTAIN VIEW,  CA  94043
Applicant Contact LARRY WOODWARD
Correspondent
TELEDIAGNOSTIC SYSTEMS, INC.
2484 OLD MIDDLEFIELD WAY
SUITE 202
MOUNTAIN VIEW,  CA  94043
Correspondent Contact LARRY WOODWARD
Regulation Number882.5050
Classification Product Code
HCC  
Subsequent Product Code
GWQ  
Date Received06/19/2007
Decision Date 09/05/2007
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Neurology
510k Review Panel Neurology
Statement Statement
Type Traditional
Reviewed by Third Party No
Combination Product No
-
-