Zmi Sae-Mc-R-Pd
by ZMI Electronics Ltd. 2 variants
Zmi Sae-Mc-R-Pd is a Class II device made by ZMI Electronics Ltd., cleared under FDA 510(k) K180865 on 28 Jun 2018 and listed in FDA GUDID since 24 Aug 2018 (UDI-DI 04719872330424), active as of 23 Oct 2026.
Active
510(k)
Valid until
No expiry
FDA recalls
None found
Documents
Trust
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | GUDID listing | Number04719872330424 | Date24 Aug 2018 | StatusListed |
| United States | FDA 510(k)SESE | NumberK180865 | Date28 Jun 2018 | StatusActive |
Official records
- AccessGUDID record 04719872330424
- FDA 510(k) database K180865
Across registries
- FDA 510(k) K180865 decided 28 Jun 2018 Active
- FDA GUDID UDI-DI 04719872330424 listed 24 Aug 2018 Listed
Timeline
- Cleared FDA 510(k) K180865
- Listed FDA GUDID 04719872330424
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- Trade name
- Zmi
- Generic name
- Neuromuscular transmission electrode
- Model / Ref / Catalog
- SAE-MC-R-PD, SAE-MC-R
- Description
- Self-adhesive electrode package (with magnetic snap) , Red, Each package contains dia.55mm (4pcs) + 50mm*90mm (2pcs)
- Primary DI / UDI-DI
- 04719872330424
- 510(k) Number
- FDA product code
- GXY
- GMDN term
- Neuromuscular transmission electrode
- Device class
- Class II
- Regulation number
- 882.1320
- GUDID distribution status
- In Commercial Distribution
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