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FDA 510(k)

SOMNOscreen plus

K-Number: K201054 · 2020-08-12

ApplicantSomnomedics GmbH
Decision Date2020-08-12
Product CodeOLV
Advisory CommitteeNE
DecisionSubstantially Equivalent

Device Summary

SOMNOscreen plus is a medical device manufactured by Somnomedics GmbH. It received FDA 510(k) clearance on 2020-08-12 under approval number K201054. The device is classified under product code OLV. It was reviewed by the NE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the SOMNOscreen plus?

SOMNOscreen plus is a medical device that received FDA 510(k) clearance on 2020-08-12. It is manufactured by Somnomedics GmbH. The 510(k) number is K201054.

When was SOMNOscreen plus approved by the FDA?

SOMNOscreen plus received FDA 510(k) clearance on 2020-08-12, under approval number K201054.

What company makes SOMNOscreen plus?

SOMNOscreen plus is manufactured by Somnomedics GmbH.

What is the FDA product code for SOMNOscreen plus?

The FDA product code for SOMNOscreen plus is OLV.

Other Devices by Somnomedics GmbH

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Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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