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KZM — Device, Muscle Monitoring Class II

FDA Device Classification

Classification Details

Product Code
KZM
Device Class
Class II
Regulation Number
890.1375
Submission Type
Review Panel
DE
Medical Specialty
Physical Medicine
Implant
No

Recent 510(k) Clearances

K-NumberApplicantDevice NameDate
K161716btsTEETHAN 2.0December 21, 2016
K130158bio-research associatesM-SCANJuly 25, 2013
K113677medotechGRINDCARE MEASUREApril 5, 2012
K082927bio-research associatesBIOEMG IIIFebruary 6, 2009
K043373neuromuscular technologiesDOLOTENS DENTAL TM 1September 2, 2005
K030869s.l.p.BITESTRIPMay 14, 2004
K003176bio-research associatesBIOEMG II AND BIOJVAJanuary 4, 2001
K003287myotronics-noromedMODEL K7 EVALUATION DEVICENovember 6, 2000
K992694myotronics-noromedMODIFICATION TO K6-I DIAGNOSTIC SYSTEM, MODEL K6-ISeptember 10, 1999
K981563bio-research associatesBIOPAK MEASUREMENT SYSTEMSeptember 15, 1998
K944134myo-tronicsK6-1 DIAGNOSTIC SYSTEM VERSION 3.1December 9, 1994
K922456myo-tronicsK6-I DIAGNOSTIC SYSTEMJune 9, 1994
K921919myo-tronicsMS-100 MYO-SCANNER OR MS-100 EMG SCANNERJanuary 7, 1993
K873947bio-research associatesBIO-EMG MODEL 800April 27, 1988
K862121electronic waveform laboratoryE.W.L. P-TENS/H-WAVEJune 17, 1987
K862092m. d. supplyCOMFORTRONOctober 15, 1986
K850425pain preventionDENTAL ANESTHESIA APPARATUSOctober 9, 1986
K830034myo-tronics researchMODEL EM-2 BIOELECTRIC PROCESSORFebruary 9, 1983
K810528myo-tronics researchMODEL EM-IRMarch 31, 1981