RTM REHABILITATION TREADMILL, MODEL #945-200

Treadmill, Powered

BIODAN MEDICAL SYSTEMS, LTD.

The following data is part of a premarket notification filed by Biodan Medical Systems, Ltd. with the FDA for Rtm Rehabilitation Treadmill, Model #945-200.

Pre-market Notification Details

Device IDK930261
510k NumberK930261
Device Name:RTM REHABILITATION TREADMILL, MODEL #945-200
ClassificationTreadmill, Powered
Applicant BIODAN MEDICAL SYSTEMS, LTD. BROOKHAVE R & D PLAZA 20 RAMSAY RD.,BOX 702 Shirley,  NY  11967
ContactClyde Schlein
CorrespondentClyde Schlein
BIODAN MEDICAL SYSTEMS, LTD. BROOKHAVE R & D PLAZA 20 RAMSAY RD.,BOX 702 Shirley,  NY  11967
Product CodeIOL  
CFR Regulation Number890.5380 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1993-01-19
Decision Date1993-05-26

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