FDA Product Code
FDA Product Code KZM — Clearance Directory
- Device Class
- Class II
- Assigned Panel
- Physical Medicine
- 21 CFR Citation
- 890.1375
510(k) Clearances — 19 records
| K-Number | Device Name | Applicant | Decision Date | Clearance Type | Summary |
|---|---|---|---|---|---|
| K161716 | TEETHAN 2.0 | Bts S.P.A. | 2016-12-21 | Traditional | PDF ↗ |
| K130158 | M-SCAN | Bio-Research Associates, Inc. | 2013-07-25 | Traditional | PDF ↗ |
| K113677 | GRINDCARE MEASURE | Medotech A/S | 2012-04-05 | Traditional | PDF ↗ |
| K082927 | BIOEMG III | Bio-Research Associates, Inc. | 2009-02-06 | Traditional | PDF ↗ |
| K043373 | DOLOTENS DENTAL TM 1 | Neuromuscular Technologies, Inc. | 2005-09-02 | Abbreviated | PDF ↗ |
| K030869 | BITESTRIP | S.L.P. , Ltd. | 2004-05-14 | Traditional | PDF ↗ |
| K003176 | BIOEMG II AND BIOJVA | Bio-Research Associates, Inc. | 2001-01-04 | Traditional | PDF ↗ |
| K003287 | MODEL K7 EVALUATION DEVICE | Myotronics-Noromed, Inc. | 2000-11-06 | Special | PDF ↗ |
| K992694 | MODIFICATION TO K6-I DIAGNOSTIC SYSTEM, MODEL K6-I | Myotronics-Noromed, Inc. | 1999-09-10 | Special | PDF ↗ |
| K981563 | BIOPAK MEASUREMENT SYSTEM | Bio-Research Associates, Inc. | 1998-09-15 | Traditional | PDF ↗ |
| K944134 | K6-1 DIAGNOSTIC SYSTEM VERSION 3.1 | Myo-Tronics, Inc. | 1994-12-09 | Traditional | PDF ↗ |
| K922456 | K6-I DIAGNOSTIC SYSTEM | Myo-Tronics, Inc. | 1994-06-09 | Traditional | PDF ↗ |
| K921919 | MS-100 MYO-SCANNER OR MS-100 EMG SCANNER | Myo-Tronics, Inc. | 1993-01-07 | Traditional | PDF ↗ |
| K873947 | BIO-EMG MODEL 800 | Bio-Research Associates, Inc. | 1988-04-27 | Traditional | PDF ↗ |
| K862121 | E.W.L. P-TENS/H-WAVE | Electronic Waveform Laboratory, Inc. | 1987-06-17 | Traditional | PDF ↗ |
| K862092 | COMFORTRON | M. D. Supply, Inc. | 1986-10-15 | Traditional | PDF ↗ |
| K850425 | DENTAL ANESTHESIA APPARATUS | Pain Prevention, Inc. | 1986-10-09 | Traditional | PDF ↗ |
| K830034 | MODEL EM-2 BIOELECTRIC PROCESSOR | Myo-Tronics Research, Inc. | 1983-02-09 | Traditional | PDF ↗ |
| K810528 | MODEL EM-IR | Myo-Tronics Research, Inc. | 1981-03-31 | Traditional | PDF ↗ |
Product code KZM · Class II · Physical Medicine. Data: openFDA.