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 K950095
Device Name CYBEX 770
Applicant
Cybex
2100 Smithtown Ave.
Ronkonkoma,  NY  11779
Applicant Contact ROBERT COHEN
Correspondent
Cybex
2100 Smithtown Ave.
Ronkonkoma,  NY  11779
Correspondent Contact ROBERT COHEN
Regulation Number890.1925
Classification Product Code
IKK  
Date Received01/10/1995
Decision Date 06/21/1995
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
-
-