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, measuring
510(k) Number K864581
Device Name APPLIDYN
Applicant
GRANDCOR MEDICAL SYSTEMS
405 GRAND AVE.
DAYTON,  OH  45405
Applicant Contact SPERO M ALEX
Correspondent
GRANDCOR MEDICAL SYSTEMS
405 GRAND AVE.
DAYTON,  OH  45405
Correspondent Contact SPERO M ALEX
Regulation Number890.5360
Classification Product Code
ISD  
Date Received11/20/1986
Decision Date 01/21/1987
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Physical Medicine
510k Review Panel Physical Medicine
Type Traditional
Reviewed by Third Party No
Combination Product No
-
-