KZM · Class II · 21 CFR 890.1375

FDA Product Code KZM: Device, Muscle Monitoring

Leading manufacturers include Bio-Research Associates, Inc., Myo-Tronics, Inc. and Myotronics-Noromed, Inc..

19
Total
19
Cleared
215d
Avg days
1981
Since

FDA 510(k) Cleared Device, Muscle Monitoring Devices (Product Code KZM)

19 devices
1–19 of 19
Cleared Dec 21, 2016
TEETHAN 2.0
K161716
Bts S.P.A.
Dental · 183d
Cleared Jul 25, 2013
M-SCAN
K130158
Bio-Research Associates, Inc.
Dental · 183d
Cleared Apr 05, 2012
GRINDCARE MEASURE
K113677
Medotech A/S
Dental · 113d
Cleared Feb 06, 2009
BIOEMG III
K082927
Bio-Research Associates, Inc.
Dental · 128d
Cleared Sep 02, 2005
DOLOTENS DENTAL TM 1
K043373
Neuromuscular Technologies, Inc.
Dental · 268d
Cleared May 14, 2004
BITESTRIP
K030869
S.L.P. , Ltd.
Dental · 422d
Cleared Jan 04, 2001
BIOEMG II AND BIOJVA
K003176
Bio-Research Associates, Inc.
Dental · 85d
Cleared Nov 06, 2000
MODEL K7 EVALUATION DEVICE
K003287
Myotronics-Noromed, Inc.
Dental · 17d
Cleared Sep 10, 1999
MODIFICATION TO K6-I DIAGNOSTIC SYSTEM, MODEL K6-I
K992694
Myotronics-Noromed, Inc.
Dental · 29d
Cleared Sep 15, 1998
BIOPAK MEASUREMENT SYSTEM
K981563
Bio-Research Associates, Inc.
Dental · 137d
Cleared Dec 09, 1994
K6-1 DIAGNOSTIC SYSTEM VERSION 3.1
K944134
Myo-Tronics, Inc.
Dental · 107d
Cleared Jun 09, 1994
K6-I DIAGNOSTIC SYSTEM
K922456
Myo-Tronics, Inc.
Dental · 744d
Cleared Jan 07, 1993
MS-100 MYO-SCANNER OR MS-100 EMG SCANNER
K921919
Myo-Tronics, Inc.
Dental · 259d
Cleared Apr 27, 1988
BIO-EMG MODEL 800
K873947
Bio-Research Associates, Inc.
Dental · 212d
Cleared Jun 17, 1987
E.W.L. P-TENS/H-WAVE
K862121
Electronic Waveform Laboratory, Inc.
Dental · 379d
Cleared Oct 15, 1986
COMFORTRON
K862092
M. D. Supply, Inc.
Dental · 135d
Cleared Oct 09, 1986
DENTAL ANESTHESIA APPARATUS
K850425
Pain Prevention, Inc.
Dental · 612d
Cleared Feb 09, 1983
MODEL EM-2 BIOELECTRIC PROCESSOR
K830034
Myo-Tronics Research, Inc.
Dental · 33d
Cleared Mar 31, 1981
MODEL EM-IR
K810528
Myo-Tronics Research, Inc.
Dental · 33d

About Product Code KZM - Regulatory Context