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510(k) K923350

Device
CLOSED CHAIN ATTACHMENT, MODEL #820-520
Applicant
BIODAN MEDICAL SYSTEMS, LTD.
510(k) number
K923350
Product code
IKK  
Decision
Substantially Equivalent (SESE)
Decision date
1992-07-23
Date received
1992-07-08
Regulation
890.1925
Classification name
System, Isokinetic Testing And Evaluation
Medical specialty
Physical Medicine
Review panel
Physical Medicine
Device class
2
Clearance type
Traditional
Statement or summary
Statement
Third party reviewed
No

Applicant Contact#

Contact
CLYDE SCHLEIN
Address
Brookhave R & D Plz. 20 Ramsay Rd.,Box 702 Shirley NY US 11967 11967

FDA Registration Numbers#

Source Documents#

510(k) summary PDF not indicated by FDA

Other 510(k) Records For Product Code IKK  #

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K123746AMES THERAPY DEVICEAmes Technology, Inc.2013-05-24
K952090HUMAC SYSTEMComputer Sports Medicine, Inc.1995-12-11
K951770BIODEX SYSTEM 3 MODEL S3S-AP AND MODEL S3D-3APBiodex Medical Systems, Inc.1995-11-16
K951916CC RIDER, MODEL ME180Mettler Electronics Corp.1995-10-04
K950095CYBEX 770Cybex1995-06-21
K942229MOTIVATOR FTR 2000Hogan & Hartson1995-02-27
K944732DEXTER ISOKINETICCedaron Medical, Inc.1995-02-03
K924414THE BTE DYNAMIC LIFTBaltimore Therapeutic Equipment Co.1993-02-12
K922772TWO POSITION ROLL-UP BACK ATTACHMENT CHAIRBiodan Medical Systems, Ltd.1992-07-13
K922092SINGLE CHAIR INTEGRAL BACK ATTACHMENTBiodan Medical Systems, Ltd.1992-05-26
K915144DEXTER HAND EVALUATION AND THERAPY SYSTEMCedars Medical Center1992-04-02
K915846BIODEX SYSTEM 2 AUTOPROGRAMBiodex Corp.1992-01-13
K915648BIODEX SYSTEM 2 AUTOPROGRAMBiodex Corp.1992-01-09
K913021BIODEX,MODEL B-2000Biodex Corp.1991-10-03
K913020BIODEX SYSTEM 2,MODEL S2-SBiodex Corp.1991-10-03

Legacy Summary#

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FDA Review#

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