Morpheus Nm-0354
Morpheus Nm-0354 is a Class II device made by Blackrock Neuromed, LLC, cleared under FDA 510(k) K071782 on 10 Jan 2008 and listed in FDA GUDID since 7 Dec 2016 (UDI-DI 00850154007079), 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 | GUDID listing | Number00850154007079 | Date7 Dec 2016 | StatusListed |
| United States | FDA 510(k)SESE | NumberK071782 | Date10 Jan 2008 | StatusActive |
Official records
- AccessGUDID record 00850154007079
- FDA 510(k) database K071782
Across registries
- FDA 510(k) K071782 decided 10 Jan 2008 Active
- FDA GUDID UDI-DI 00850154007079 listed 7 Dec 2016 Listed
Timeline
- Cleared FDA 510(k) K071782
- Listed FDA GUDID 00850154007079
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- Trade name
- Morpheus
- Generic name
- Electroencephalography telemetric monitoring system
- Model / Ref / Catalog
- NM-0354
- Primary DI / UDI-DI
- 00850154007079
- 510(k) Number
- FDA product code
- GWL, GWQ, OLV, GWK
- GMDN term
- Electroencephalography telemetric monitoring system
- Device class
- Class II
- Regulation number
- 882.1835, 882.1400, 882.1845
- GUDID distribution status
- In Commercial Distribution
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