Myosystem 1000 Electromyograph
510(k) K895635
Myosystem 1000 Electromyograph is a Class II device made by Noraxon USA, Inc., cleared under FDA 510(k) K895635 on 19 Apr 1990, active as of 22 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 | NumberK895635 | Date19 Apr 1990 | StatusActive |
Official records
- FDA 510(k) database K895635
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- 510(k) Number
- FDA product code
- HCC
- Device class
- Class II
- Regulation
- 21 CFR Part 882.5050
- Advisory committee
- Neurology
- FDA decision
- SESE Substantially Equivalent
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