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 Couch, Radiation Therapy, Powered
510(k) Number K034054
Device Name PRO SERIES COUCH SOFTWARE, MODEL MT-PRO100
Applicant
Med-Tec,Inc.
1401 8th St., SE
P.O. Box 320
Orange City,  IA  51041
Applicant Contact DONALD F RIIBE
Correspondent
Med-Tec,Inc.
1401 8th St., SE
P.O. Box 320
Orange City,  IA  51041
Correspondent Contact DONALD F RIIBE
Regulation Number892.5770
Classification Product Code
JAI  
Date Received12/30/2003
Decision Date 02/20/2004
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Statement Statement
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
-
-