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 Image-Intensified Fluoroscopic X-Ray System, Mobile
510(k) Number K934700
Device Name MODEL 90P PORTABLE MEDICAL DIAGNOSTIC X-RAY
Applicant
Tempo Technology, Inc.
2090 W. Dowell Rd.
Columbia City,  IN  46725
Applicant Contact CHRISTOPHER E DARE
Correspondent
Tempo Technology, Inc.
2090 W. Dowell Rd.
Columbia City,  IN  46725
Correspondent Contact CHRISTOPHER E DARE
Regulation Number892.1650
Classification Product Code
OXO  
Date Received09/30/1993
Decision Date 03/16/1994
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
-
-