SOMNOscreen plus— 510(k) K201054
Substantially EquivalentSomnomedics GmbH
FDA 510(k) clearance K201054 for SOMNOscreen plus, Substantially Equivalent on 2020-08-12. Applicant: Somnomedics GmbH. Device class: 2.
Clearance details
- Applicant
- Somnomedics GmbH
- Product code
- Code OLV
- Device class
- Class 2
- Regulation
- 21 CFR 882.1400
- Advisory panel
- Neurology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Randersacker, DE
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