BIODEX SYSTEM 2 AUTOPROGRAM

System, Isokinetic Testing And Evaluation

BIODEX CORP.

The following data is part of a premarket notification filed by Biodex Corp. with the FDA for Biodex System 2 Autoprogram.

Pre-market Notification Details

Device IDK915648
510k NumberK915648
Device Name:BIODEX SYSTEM 2 AUTOPROGRAM
ClassificationSystem, Isokinetic Testing And Evaluation
Applicant BIODEX CORP. 20 RAMSAY RD. P.O. BOX 702 Shirley,  NY  11967
ContactClyde Schlein
CorrespondentClyde Schlein
BIODEX CORP. 20 RAMSAY RD. P.O. BOX 702 Shirley,  NY  11967
Product CodeIKK  
CFR Regulation Number890.1925 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1991-12-13
Decision Date1992-01-09

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.