SOMNOscreen plus— 510(k) K201054

Substantially Equivalent

Somnomedics GmbH

FDA 510(k) clearance K201054 for SOMNOscreen plus, Substantially Equivalent on 2020-08-12. Applicant: Somnomedics GmbH.

Clearance details

Applicant: Somnomedics GmbH
Product code: Code OLV
Advisory panel: Neurology
Date received: 2020-04-21
Decision date: 2020-08-12
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Randersacker, DE

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