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 Exerciser, Powered
510(k) Number K931736
Device Name M-FLEX 5000 C3PMD
Applicant
Medical Systems Corp.
C/O Richard Hamer Assoc.Inc.
P.O.Box 16598
Fort Woth,  TX  76162
Applicant Contact CHERYL A BOYCE
Correspondent
Medical Systems Corp.
C/O Richard Hamer Assoc.Inc.
P.O.Box 16598
Fort Woth,  TX  76162
Correspondent Contact CHERYL A BOYCE
Regulation Number890.5380
Classification Product Code
BXB  
Date Received04/07/1993
Decision Date 01/27/1994
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Physical Medicine
510k Review Panel Physical Medicine
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
-
-