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FDA 510(k)

SOMNOSCREEN EEG10-20

K-Number: K071556 · 2007-07-18

ApplicantSomnomedics GmbH
Decision Date2007-07-18
Product CodeMNR
Advisory CommitteeAN
DecisionSubstantially Equivalent

Device Summary

SOMNOSCREEN EEG10-20 is the device name listed in this FDA 510(k) record. The listed applicant is Somnomedics GmbH. It received FDA 510(k) clearance on 2007-07-18 under 510(k) number K071556. 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 EEG10-20?

SOMNOSCREEN EEG10-20 is a medical device that received FDA 510(k) clearance on 2007-07-18. The listed applicant is Somnomedics GmbH. The 510(k) number is K071556.

When did SOMNOSCREEN EEG10-20 receive FDA 510(k) clearance?

SOMNOSCREEN EEG10-20 received FDA 510(k) clearance on 2007-07-18, under 510(k) number K071556.

Who is the listed applicant for SOMNOSCREEN EEG10-20?

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

What is the FDA product code for SOMNOSCREEN EEG10-20?

The FDA product code for SOMNOSCREEN EEG10-20 is MNR.

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Other records listing Somnomedics GmbH as applicant

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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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