K7 EMG Electromyograph
K7 EMG Electromyograph (0995) is a patient monitoring system module (FDA Class II; FDA product code KZM, Device, Muscle Monitoring) made by Myotronics-Noromed, Inc., listed in FDA GUDID since 18 Aug 2016 (UDI-DI D79209950), registry data as of 21 Oct 2026.
Listed
Valid until
Not applicable
FDA recalls
Not checked
Documents
None
Trust
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | GUDID listing | NumberD79209950 | Date18 Aug 2016 | StatusListed |
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — GUDID listing Listed
Specification
- Generic name
- Patient monitoring system module, electromyographic
- Model / Ref / Catalog
- EMG, 0995
- Primary DI / UDI-DI
- D79209950
- FDA product code
- KZM
- GMDN term
- Patient monitoring system module, electromyographic
- Device class
- Class II
- Regulation number
- 890.1375
- GUDID distribution status
- In Commercial Distribution
Similar devices
Other devices filed under FDA product code KZM (Device, Muscle Monitoring).
- BITESTRIP by S.L.P. Ltd.
- K6-1 Diagnostic System Version 3.1 by Myo-Tronics, Inc.
- Model EM-IR by Myo-Tronics Research, Inc.
- K6-I Diagnostic System by Myo-Tronics, Inc.
- Dolotens Dental 1 by Neuromuscular Technologies, Inc.
- GRINDCARE MEASURE by Medotech A/S
- DENTAL ANESTHESIA APPARATUS by Pain Prevention, Inc.
- BIO-EMG MODEL 800 by BIO-RESEARCH ASSOCIATES, INC.
- BIOEMG III by BIO-RESEARCH ASSOCIATES, INC.
- Nox C1 Kit NOX-C1KIT1 544020 by Nox Medical