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FDA 510(k)

Somfit D

K-Number: K252383 · 2025-08-28

ApplicantCompumedics Limited
Decision Date2025-08-28
Product CodeMNR
Advisory CommitteeAN
DecisionSubstantially Equivalent

Device Summary

Somfit D is a medical device manufactured by Compumedics Limited. It received FDA 510(k) clearance on 2025-08-28 under approval number K252383. 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 Somfit D?

Somfit D is a medical device that received FDA 510(k) clearance on 2025-08-28. It is manufactured by Compumedics Limited. The 510(k) number is K252383.

When was Somfit D approved by the FDA?

Somfit D received FDA 510(k) clearance on 2025-08-28, under approval number K252383.

What company makes Somfit D?

Somfit D is manufactured by Compumedics Limited.

What is the FDA product code for Somfit D?

The FDA product code for Somfit D is MNR.

Other Devices by Compumedics Limited

K191785Orion LifeSpan MEG K231546Somfit K230073Okti K242447Falcon HST

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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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