Sandman Elite
510(k) K153353
Sandman Elite is a Class II device made by Embla Systems, cleared under FDA 510(k) K153353 on 23 Jun 2016, 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 | NumberK153353 | Date23 Jun 2016 | StatusActive |
Official records
- FDA 510(k) database K153353
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- 510(k) Number
- FDA product code
- OLZ
- Device class
- Class II
- Regulation
- 21 CFR Part 882.1400
- Advisory committee
- Neurology
- FDA decision
- SESE Substantially Equivalent
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