510(k) Premarket Notification

510(k) | Registration & Listing | Adverse Events | Recalls | PMA | Classification | Standards CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA

New Search Back To Search Results Device Classification Name system, isokinetic testing and evaluation 510(k) Number K915846 Device Name BIODEX SYSTEM 2 AUTOPROGRAM Applicant BIODEX CORP. 20 ramsay rd. p.o. box 702 shirley,  NY  11967 Contact clyde schlein Regulation Number 890.1925 Classification Product Code IKK   Date Received 12/13/1991 Decision Date 01/13/1992 Decision substantially equivalent (SE) Classification Advisory Committee Physical Medicine Review Advisory Committee Physical Medicine Statement/Summary/Purged Status Summary only Type Traditional Reviewed by Third Party No Expedited Review