FDA 510(k)
FDA class 2
Substantially Equivalent
🇮🇸 Iceland
Noxturnal Web
K Number: K241288
·
Decision Dec 23, 2024
Classifications
1
FEI Numbers
48
Registration Numbers
48
Same Product Code
63
Applicant Total
5
Review Days
230
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Basic Information
- Device Name
- Noxturnal Web
- K Number
- K241288
- 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 Ehf
- Date Received
- May 7, 2024
- Decision Date
- December 23, 2024
- Product Code
- OLV
- 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 |
|---|---|---|---|
| OLV | Standard Polysomnograph With Electroencephalograph | FDA class 2 | Neurology |
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