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510(k) K942694

Device
STABILITY SYSTEM (110V) MODEL 945-300; STABILITY SYSTEM (220V) MODEL #945-302
Applicant
BIODEX MEDICAL SYSTEMS, INC.
510(k) number
K942694
Product code
KHX  
Decision
Substantially Equivalent (SESE)
Decision date
1995-03-10
Date received
1994-06-07
Regulation
890.1575
Classification name
Platform, Force-measuring
Medical specialty
Physical Medicine
Review panel
Physical Medicine
Device class
1
Clearance type
Traditional
Statement or summary
Summary
Third party reviewed
No

Applicant Contact#

Contact
CLYDE SCHLEIN
Address
Brookhaven R & D Plz. 20 Ramsey Rd., P.O. Box 702 Shirley NY US 11967 11967

FDA Registration Numbers#

Source Documents#

510(k) summary PDF

Other 510(k) Records For Product Code KHX  #

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K951771COMMUNITY BALANCE PERFORMANCE MONITOR OR COMMUNITY BPMSms Technologies, Ltd.1995-08-11
K946229BALANCE MANAGERNeurocom International, Inc.1995-08-04
K930089SMS BALANCE PERFORMANCE MONITORSms Technologies, Ltd.1993-06-08
K921340FORCE MEASURING PLATFORMSra Intl., Inc.1992-05-26
K901069COMPUTERIZED FUNCTIONAL TESTING GAIT SYSTEMComputerized Functional Testing Corp.1990-03-16
K893254DYNAMIC SYSTEM COMPUTERIZED PODIATRIC ANALYZERDalphi, Inc.1990-01-02
K883129BIOMECHANICS FORCE PLATFORM/#OR 6-6-1000 & 2000Advanced Mechanical Technology, Inc.1988-10-24
K883130BIOMECHANICS FORCE PLATFORM/# OR6-5-1000 & 2000Advanced Mechanical Technology, Inc.1988-10-24
K883131BIOMECHANICS FORCE PLATFORM #LG6-4-1000 & 2000Advanced Mechanical Technology, Inc.1988-10-24
K883198BIOVEC BIOMECHANIC FORCE ANALYSIS SYSTEMAdvanced Mechanical Technology, Inc.1988-10-24
K883127MULTI-CHANNEL STRAIN-GAGE AMPLIFIER & POWER SUPPLYAdvanced Mechanical Technology, Inc.1988-09-30
K863443DUAL FORCEPLATENeurocom International, Inc.1986-09-17
K821255ELECTRODYNOGRAM SYSTEMThe Langer Group1982-07-02
K820444HEART-ALERTMedical Equipment Devices, Inc.1982-03-12

Legacy Summary#

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FDA Review#

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