BIODEX SYSTEM 2,MODEL S2-S

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,model S2-s.

Pre-market Notification Details

Device IDK913020
510k NumberK913020
Device Name:BIODEX SYSTEM 2,MODEL S2-S
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 Received1991-07-09
Decision Date1991-10-03

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