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 System, Isokinetic Testing And Evaluation
510(k) Number K951770
Device Name BIODEX SYSTEM 3 MODEL S3S-AP AND MODEL S3D-3AP
Applicant
Biodex Medical Systems, Inc.
20 Ramsay Rd.
Box 702
Shirley,  NY  11967
Applicant Contact CLYDE SCHLEIN
Correspondent
Biodex Medical Systems, Inc.
20 Ramsay Rd.
Box 702
Shirley,  NY  11967
Correspondent Contact CLYDE SCHLEIN
Regulation Number890.1925
Classification Product Code
IKK  
Date Received04/17/1995
Decision Date 11/16/1995
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Physical Medicine
510k Review Panel Physical Medicine
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
-
-