FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
NicoletOne
K Number: K173366
·
Decision Jul 20, 2018
Classifications
1
FEI Numbers
24
Registration Numbers
24
Same Product Code
35
Applicant Total
5
Review Days
267
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Basic Information
- Device Name
- NicoletOne
- K Number
- K173366
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 882.1400
- Medical Specialty
- Neurology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Natus Neurology Incorporated
- Date Received
- October 26, 2017
- Decision Date
- July 20, 2018
- Product Code
- OLZ
- Advisory Committee
- Neurology
- Review Advisory Committee
- NE
- Third Party
- N
Classifications
This FDA 510(k) entry is associated with 1 FDA classification via its product code.
| Product Code | Device Name | Device Class | Medical Specialty |
|---|---|---|---|
| OLZ | Automatic Event Detection Software For Polysomnograph With Electroencephalograph | FDA class 2 | Neurology |
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Other Clearances by Natus Neurology Incorporated
| K Number | Device Name | ||
|---|---|---|---|
| K243982 | Nicolet EDX | Jan 22, 2025 | Substantially Equivalent |
| K243495 | Natus Ultrapro S100 (982A0594) | Dec 12, 2024 | Substantially Equivalent |
| K172743 | Natus VikingQuest | Dec 19, 2017 | Substantially Equivalent |
| K130346 | SYNERGY FOCUS DESKTOP VERSION; SYNERGY FOCUS LAPTOP VERSION | May 2, 2013 | Substantially Equivalent |