510(k) K931321

Device
CSD 200/300/400/500 DYNAMOMETER
Applicant
JOHN CHATILLON & SONS, INC.
510(k) number
K931321
Product code
LBB  
Decision
Substantially Equivalent (SESE)
Decision date
1994-02-15
Date received
1993-03-16
Regulation
888.1240
Classification name
Dynamometer, Ac-powered
Medical specialty
Orthopedic
Review panel
Neurology
Device class
2
Clearance type
Traditional
Statement or summary
Summary
Third party reviewed
No

Applicant Contact#

Contact
KAMPERMAN
Address
P.O. Box 35668 Greensboro NC US 27425 27425

FDA Registration Numbers#

Source Documents#

510(k) summary PDF

Other 510(k) Records For Product Code LBB  #

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K162412Hoggan Scientific® microFET2™Hoggan Scientific, LLC2017-03-09
K073154FACTS HAND AND PINCH GRIP COMBOGlobal Services Group, LLC2008-02-14
K052309DIGITAL HAND DYNAMOMETER, MODEL SH5003; DIGITAL PINCH GAUGE, MODEL SH5006Saehan Corp.2005-09-27
K042889DYNAMOMETER - MODEL FCE AND MODEL MSCAmetek2004-11-16
K012492KADANCE 2000Kada Research, Inc.2001-11-02
K981730DIGIT-GRIP WITH LCD, MODEL NUMBER DGR 002Nk Biotechnical Corp.1998-07-17
K980363ORO-FACIAL MYOGRAPHIC MEASUREMENT INSTRUMENT (OMMI)Orofacial Dynamics1998-04-16
K964933MEKANIKA'S SPINAL STIFFNESS GAUGE (SSG)Mekanika, Inc.1997-02-03
K964685DYNAMOMETERJohn Chatillon & Sons, Inc.1997-01-27
K935757GREENLEAF EVAL SYSTEM/ GREENLEAF SOLOSYSTEMGreenleaf Medical Systems, Inc.1994-04-15
K923965NK GRASP SENSOR, MODEL GA002Nk Biotechnical Engineering Co.1993-05-12
K923964NK GRASP SENSOR, MODEL GA001Nk Biotechnical Engineering Co.1993-05-12
K923963NK DIGI-GRIP SENSOR, MODEL DGR001Nk Biotechnical Engineering Co.1993-03-31
K923262DMG100 AND 500 ISOMETRIC STRENGTH DYNAMOMETERJohn Chatillon & Sons, Inc.1992-10-27
K922029REMUSK MPEquipement Biomedical Specialise, Inc.1992-10-06

Legacy Summary#

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FDA Review#

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