PowerDot SAE-MC-B-200BFLP
PowerDot SAE-MC-B-200BFLP 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 10 Dec 2019 (UDI-DI 04719872330639), 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 | Number04719872330639 | Date10 Dec 2019 | StatusListed |
| United States | FDA 510(k)SESE | NumberK180865 | Date28 Jun 2018 | StatusActive |
Official records
- AccessGUDID record 04719872330639
- FDA 510(k) database K180865
Across registries
- FDA 510(k) K180865 decided 28 Jun 2018 Active
- FDA GUDID UDI-DI 04719872330639 listed 10 Dec 2019 Listed
Timeline
- Cleared FDA 510(k) K180865
- Listed FDA GUDID 04719872330639
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- Trade name
- PowerDot
- Generic name
- Neuromuscular transmission electrode
- Model / reference
- SAE-MC-B-200BFLP
- Primary DI / UDI-DI
- 04719872330639
- 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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