Model K7 Evaluation Device
510(k) K003287
Model K7 Evaluation Device is a medical device (FDA Class II; FDA product code KZM, Device, Muscle Monitoring) made by Myotronics-Noromed, Inc., cleared under FDA 510(k) K003287 on 6 Nov 2000, active as of 10 Oct 2026.
Active
510(k)
Valid until
No expiry
FDA recalls
None found
Documents
Trust
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK003287 | Date6 Nov 2000 | StatusActive |
Official records
- FDA 510(k) database K003287
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- 510(k) Number
- FDA product code
- KZM
- Device class
- Class II
- Regulation
- 21 CFR Part 890.1375
- Advisory committee
- Physical Medicine
- FDA decision
- SESE Substantially Equivalent
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