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, Galvanic Skin Response Measurement
510(k) Number K023355
Device Name ASYRA
Applicant
Galloway Technologies, LLC
3736 Panarama Dr.
Saratoga Springs,  UT  84043
Applicant Contact JOE GALLOWAY
Correspondent
Galloway Technologies, LLC
3736 Panarama Dr.
Saratoga Springs,  UT  84043
Correspondent Contact JOE GALLOWAY
Regulation Number882.1540
Classification Product Code
GZO  
Date Received10/07/2002
Decision Date 06/24/2003
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Neurology
510k Review Panel Neurology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
-
-