NicoletOne
by Natus Neurology Incorporated
510(k) K173366
NicoletOne is a Class II device made by Natus Neurology Incorporated, cleared under FDA 510(k) K173366 on 20 Jul 2018, 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 | NumberK173366 | Date20 Jul 2018 | StatusActive |
Official records
- FDA 510(k) database K173366
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- Withdrawn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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