FDA 510(k)
FDA class 2
Substantially Equivalent
🇮🇸 Iceland
Nox Sleep System
K Number: K192469
·
Decision Nov 13, 2019
Classifications
1
FEI Numbers
24
Registration Numbers
24
Same Product Code
35
Applicant Total
3
Review Days
65
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Basic Information
- Device Name
- Nox Sleep System
- K Number
- K192469
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 882.1400
- Medical Specialty
- Neurology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Nox Medical
- Date Received
- September 9, 2019
- Decision Date
- November 13, 2019
- 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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