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FDA 510(k)

SOMNOSCREEN

K-Number: K060708 · 2007-01-24

ApplicantSomnomedics GmbH & Co. KG
Decision Date2007-01-24
Product CodeMNR
Advisory CommitteeAN
DecisionSubstantially Equivalent

Device Summary

SOMNOSCREEN is the device name listed in this FDA 510(k) record. The listed applicant is Somnomedics GmbH & Co. KG. It received FDA 510(k) clearance on 2007-01-24 under 510(k) number K060708. The device is classified under product code MNR. It was reviewed by the AN advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the SOMNOSCREEN?

SOMNOSCREEN is a medical device that received FDA 510(k) clearance on 2007-01-24. The listed applicant is Somnomedics GmbH & Co. KG. The 510(k) number is K060708.

When did SOMNOSCREEN receive FDA 510(k) clearance?

SOMNOSCREEN received FDA 510(k) clearance on 2007-01-24, under 510(k) number K060708.

Who is the listed applicant for SOMNOSCREEN?

The FDA 510(k) record lists Somnomedics GmbH & Co. KG as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for SOMNOSCREEN?

The FDA product code for SOMNOSCREEN is MNR.

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Official Source

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

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