FDA.report

510(k) K980363

Device
Oro-facial Myographic Measurement Instrument (ommi)
Applicant
OROFACIAL DYNAMICS
510(k) number
K980363
Product code
LBB
Decision
Substantially Equivalent (SESE)
Decision date
1998-04-16
Date received
1998-01-29
Regulation
888.1240
Classification name
Dynamometer, Ac-Powered
Medical specialty
Orthopedic
Review panel
Orthopedic
Device class
2
Clearance type
Traditional
Statement or summary
Summary
Third party reviewed
No

Related Records

Applicant Contact

Contact
RONALD E TURA
Address
P.O. Box 1082 Alamo CA US 94507 94507

FDA Registration Numbers

Source Documents

510(k) summary PDF

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K012492KADANCE 2000Kada Research, Inc.2001-11-02
K981730DIGIT-GRIP WITH LCD, MODEL NUMBER DGR 002Nk Biotechnical Corp.1998-07-17
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K964685DYNAMOMETERJohn Chatillon & Sons, Inc.1997-01-27
K935757GREENLEAF EVAL SYSTEM/ GREENLEAF SOLOSYSTEMGreenleaf Medical Systems, Inc.1994-04-15
K931321CSD 200/300/400/500 DYNAMOMETERJohn Chatillon & Sons, Inc.1994-02-15
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