Panels › Physical Medicine › Product code KZM · Class 2
Device, Muscle Monitoring
Regulation 890.1375
0510(k)s in 12 months (19 all time)
0recalls in 12 months (0 all time)
0recalls that name a 510(k)
Top companies in KZM
| Company | 510(k)s | Recalls |
|---|---|---|
| Bio-Research Associates, Inc. | 5 | 0 |
| Myo-Tronics, Inc. | 3 | 0 |
| Myo-Tronics Research, Inc. | 2 | 0 |
| Myotronics-Noromed, Inc. | 2 | 0 |
| Bts S.P.A. | 1 | 0 |
| Electronic Waveform Laboratory, Inc. | 1 | 0 |
| M. D. Supply, Inc. | 1 | 0 |
| Medotech A/S | 1 | 0 |
| Neuromuscular Technologies, Inc. | 1 | 0 |
| Pain Prevention, Inc. | 1 | 0 |
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Dec 21, 2016 | K161716 | TEETHAN 2.0 Bts S.P.A., IT | KZM |
| Jul 25, 2013 | K130158 | M-SCAN Bio-Research Associates, Inc. | KZM |
| Apr 5, 2012 | K113677 | GRINDCARE MEASURE Medotech A/S | KZM |
| Feb 6, 2009 | K082927 | BIOEMG III Bio-Research Associates, Inc. | KZM |
| Sep 2, 2005 | K043373 | DOLOTENS DENTAL TM 1 Neuromuscular Technologies, Inc. | KZM |
| May 14, 2004 | K030869 | BITESTRIP S.L.P. , Ltd., IL | KZM |
| Jan 4, 2001 | K003176 | BIOEMG II AND BIOJVA Bio-Research Associates, Inc. | KZM |
| Nov 6, 2000 | K003287 | MODEL K7 EVALUATION DEVICE Myotronics-Noromed, Inc. | KZM |
| Sep 10, 1999 | K992694 | MODIFICATION TO K6-I DIAGNOSTIC SYSTEM, MODEL K6-I Myotronics-Noromed, Inc. | KZM |
| Sep 15, 1998 | K981563 | BIOPAK MEASUREMENT SYSTEM Bio-Research Associates, Inc. | KZM |
| Dec 9, 1994 | K944134 | K6-1 DIAGNOSTIC SYSTEM VERSION 3.1 Myo-Tronics, Inc. | KZM |
| Jun 9, 1994 | K922456 | K6-I DIAGNOSTIC SYSTEM Myo-Tronics, Inc. | KZM |
| Jan 7, 1993 | K921919 | MS-100 MYO-SCANNER OR MS-100 EMG SCANNER Myo-Tronics, Inc. | KZM |
| Apr 27, 1988 | K873947 | BIO-EMG MODEL 800 Bio-Research Associates, Inc. | KZM |
| Jun 17, 1987 | K862121 | E.W.L. P-TENS/H-WAVE Electronic Waveform Laboratory, Inc. | KZM |
| Oct 15, 1986 | K862092 | COMFORTRON M. D. Supply, Inc. | KZM |
| Oct 9, 1986 | K850425 | DENTAL ANESTHESIA APPARATUS Pain Prevention, Inc. | KZM |
| Feb 9, 1983 | K830034 | MODEL EM-2 BIOELECTRIC PROCESSOR Myo-Tronics Research, Inc. | KZM |
| Mar 31, 1981 | K810528 | MODEL EM-IR Myo-Tronics Research, Inc. | KZM |
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