KZM
19 FDA 510(k) clearances · Product code
137 daysmedian time to decision
612 days90th percentile
19clearances measured
FDA profile
- Official device name
- Device, Muscle Monitoring
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 890.1375
- Medical specialty
- Physical Medicine
- Flags
- Third-party review eligible
Export predicate table (CSV) Shareable report ◉ Watch exports: 3 free/month · reports & watching: free
| Record | Firm | Date |
|---|---|---|
| TEETHAN 2.0 (K161716) | Bts S.P.A. | 2016-12-21 |
| M-SCAN (K130158) | Bio-Research Associates, Inc. | 2013-07-25 |
| GRINDCARE MEASURE (K113677) | Medotech A/S | 2012-04-05 |
| BIOEMG III (K082927) | Bio-Research Associates, Inc. | 2009-02-06 |
| DOLOTENS DENTAL TM 1 (K043373) | Neuromuscular Technologies, Inc. | 2005-09-02 |
| BITESTRIP (K030869) | S.L.P. , Ltd. | 2004-05-14 |
| BIOEMG II AND BIOJVA (K003176) | Bio-Research Associates, Inc. | 2001-01-04 |
| MODEL K7 EVALUATION DEVICE (K003287) | Myotronics-Noromed, Inc. | 2000-11-06 |
| MODIFICATION TO K6-I DIAGNOSTIC SYSTEM, MODEL K6-I (K992694) | Myotronics-Noromed, Inc. | 1999-09-10 |
| BIOPAK MEASUREMENT SYSTEM (K981563) | Bio-Research Associates, Inc. | 1998-09-15 |
| K6-1 DIAGNOSTIC SYSTEM VERSION 3.1 (K944134) | Myo-Tronics, Inc. | 1994-12-09 |
| K6-I DIAGNOSTIC SYSTEM (K922456) | Myo-Tronics, Inc. | 1994-06-09 |
| MS-100 MYO-SCANNER OR MS-100 EMG SCANNER (K921919) | Myo-Tronics, Inc. | 1993-01-07 |
| BIO-EMG MODEL 800 (K873947) | Bio-Research Associates, Inc. | 1988-04-27 |
| E.W.L. P-TENS/H-WAVE (K862121) | Electronic Waveform Laboratory, Inc. | 1987-06-17 |
| COMFORTRON (K862092) | M. D. Supply, Inc. | 1986-10-15 |
| DENTAL ANESTHESIA APPARATUS (K850425) | Pain Prevention, Inc. | 1986-10-09 |
| MODEL EM-2 BIOELECTRIC PROCESSOR (K830034) | Myo-Tronics Research, Inc. | 1983-02-09 |
| MODEL EM-IR (K810528) | Myo-Tronics Research, Inc. | 1981-03-31 |
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Every clearance here is in the API, with alerts when new ones post.