Nox Sleep System— 510(k) K192469
Substantially EquivalentNox Medical
FDA 510(k) clearance K192469 for Nox Sleep System, Substantially Equivalent on 2019-11-13. Applicant: Nox Medical. Device class: 2.
Clearance details
- Applicant
- Nox Medical
- Product code
- Code OLZ
- Device class
- Class 2
- Regulation
- 21 CFR 882.1400
- Advisory panel
- Neurology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Reykjavik, IS
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