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FDA 510(k)

Somfit D

K-Number: K252383 · 2025-08-28

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

Device Summary

Somfit D is the device name listed in this FDA 510(k) record. The listed applicant is Compumedics Limited. It received FDA 510(k) clearance on 2025-08-28 under 510(k) 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. The listed applicant is Compumedics Limited. The 510(k) number is K252383.

When did Somfit D receive FDA 510(k) clearance?

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

Who is the listed applicant for Somfit D?

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

What is the FDA product code for Somfit D?

The FDA product code for Somfit D is MNR.

Other records listing Compumedics Limited as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

Related Devices (Code: MNR)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

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.