Product code KZM
- Device name
- Device, Muscle Monitoring
- Medical specialty
- Physical Medicine
- Device class
- 2
- Regulation number
- 890.1375
- Review panel
- DE
- Implant
- N
- Life sustaining/supporting
- N
- GMP exempt
- N
- Third party review
- Y
- Summary malfunction reporting
- Eligible
- Source
- FDA openFDA device classification dataset
Related 510(k) Records#
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K161716 | TEETHAN 2.0 | Bts S.P.A. | 2016-12-21 |
| K130158 | M-SCAN | Bio-Research Associates, Inc. | 2013-07-25 |
| K113677 | GRINDCARE MEASURE | Medotech A/S | 2012-04-05 |
| K082927 | BIOEMG III | Bio-Research Associates, Inc. | 2009-02-06 |
| K043373 | DOLOTENS DENTAL TM 1 | Neuromuscular Technologies, Inc. | 2005-09-02 |
| K030869 | BITESTRIP | S.L.P. , Ltd. | 2004-05-14 |
| K003176 | BIOEMG II AND BIOJVA | Bio-Research Associates, Inc. | 2001-01-04 |
| K003287 | MODEL K7 EVALUATION DEVICE | Myotronics-Noromed, Inc. | 2000-11-06 |
| K992694 | MODIFICATION TO K6-I DIAGNOSTIC SYSTEM, MODEL K6-I | Myotronics-Noromed, Inc. | 1999-09-10 |
| K981563 | BIOPAK MEASUREMENT SYSTEM | Bio-Research Associates, Inc. | 1998-09-15 |
| K944134 | K6-1 DIAGNOSTIC SYSTEM VERSION 3.1 | Myo-Tronics, Inc. | 1994-12-09 |
| K922456 | K6-I DIAGNOSTIC SYSTEM | Myo-Tronics, Inc. | 1994-06-09 |
| K921919 | MS-100 MYO-SCANNER OR MS-100 EMG SCANNER | Myo-Tronics, Inc. | 1993-01-07 |
| K873947 | BIO-EMG MODEL 800 | Bio-Research Associates, Inc. | 1988-04-27 |
| K862121 | E.W.L. P-TENS/H-WAVE | Electronic Waveform Laboratory, Inc. | 1987-06-17 |
| K862092 | COMFORTRON | M. D. Supply, Inc. | 1986-10-15 |
| K850425 | DENTAL ANESTHESIA APPARATUS | Pain Prevention, Inc. | 1986-10-09 |
| K830034 | MODEL EM-2 BIOELECTRIC PROCESSOR | Myo-Tronics Research, Inc. | 1983-02-09 |
| K810528 | MODEL EM-IR | Myo-Tronics Research, Inc. | 1981-03-31 |
Related GUDID Devices#
| Primary DI | Brand | Company | Published |
|---|---|---|---|
| 00860003499962 | M-Scan | Bio-Research Associates, Inc. | 2023-06-22 |
| 00860003499955 | M-Scan | Bio-Research Associates, Inc. | 2023-06-22 |
| 00860003499948 | BioPAK | Bio-Research Associates, Inc. | 2023-06-22 |
| 00860003499900 | BioEMG | Bio-Research Associates, Inc. | 2023-06-22 |
| 15694311111665 | Noxturnal US APP | Nox Medical ehf. | 2021-10-18 |
| 15694311111627 | Nox A1® EEG Head Cable | Nox Medical ehf. | 2021-09-07 |
| 15694311111610 | Nox A1® EEG 5 Lead Gold Electrode Cable | Nox Medical ehf. | 2021-09-07 |
| 15694311111566 | Nox A1s Recorder | Nox Medical ehf. | 2021-07-10 |
| 15694311111580 | Nox A1s System | Nox Medical ehf. | 2021-07-10 |
| 15694311111597 | Nox C1s Kit | Nox Medical ehf. | 2021-07-10 |
| 15694311110699 | Nox A1 Starter Sensor Kit, Pediatric | Nox Medical ehf. | 2021-02-03 |
| 15694311110682 | Nox A1 Starter Sensor Kit, Adult | Nox Medical ehf. | 2021-02-03 |
| 15694311111498 | Nox C1 Access Point | Nox Medical ehf. | 2021-02-03 |
| 15694311111504 | Nox C1 Kit | Nox Medical ehf. | 2021-02-03 |
| 00860001651911 | HindexRV | HHS SYSTEMS, INC. | 2021-01-20 |
| 15694311110521 | Nox A1 EEG Head Cable | Nox Medical ehf. | 2020-04-27 |
| 15694311110453 | Nox A1 EEG 5 Lead Gold Electrode Cable | Nox Medical ehf. | 2020-04-27 |
| 15694311111375 | Nox A1 System | Nox Medical ehf. | 2020-02-24 |
| 15694311111368 | Noxturnal PSG CD | Nox Medical ehf. | 2020-02-24 |
| 15694311111146 | Nox C1 Kit | Nox Medical ehf. | 2020-02-24 |
| 15694311110903 | Nox A1 Recorder | Nox Medical ehf. | 2020-02-24 |
| 15694311110590 | Nox C1 Access Point | Nox Medical ehf. | 2020-02-24 |
| 15694311110019 | Noxturnal APP | Nox Medical ehf. | 2020-02-24 |
| B179THN2 | TEETHAN | BTS SPA | 2017-09-26 |
| D79209750 | K7 Evaluation System-ESG | MYOTRONICS NOROMED, INC | 2016-09-19 |
| D79209930 | K7 Evaluation System-EMG | MYOTRONICS NOROMED, INC | 2016-09-19 |
| D79209940 | K7 Evaluation System-CMS | MYOTRONICS NOROMED, INC | 2016-09-19 |
| D792N150MES0 | MES 9000 Static Electromyography Scanner | MYOTRONICS NOROMED, INC | 2016-09-19 |
| D792N9000M0 | MES 9000 Musculoskeletal System | MYOTRONICS NOROMED, INC | 2016-09-19 |
| D792N9600A0 | MES 9000 Muscle Tester | MYOTRONICS NOROMED, INC | 2016-09-19 |