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 Goniometer, Ac-Powered
510(k) Number K954647
Device Name INCLINOMETER
Applicant
J-Tech, Inc.
50 W. Canyon Rd.
Alpine,  UT  84004
Applicant Contact J. TRACY LIVINGSTON
Correspondent
J-Tech, Inc.
50 W. Canyon Rd.
Alpine,  UT  84004
Correspondent Contact J. TRACY LIVINGSTON
Regulation Number888.1500
Classification Product Code
KQX  
Date Received10/10/1995
Decision Date 10/30/1995
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Orthopedic
510k Review Panel Neurology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
-
-