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FDA 510(k)

Somfit

K-Number: K231546 · 2023-11-30

ApplicantCompumedics Limited
Decision Date2023-11-30
Product CodeMNR
Advisory CommitteeAN
DecisionSubstantially Equivalent

Device Summary

Somfit is a medical device manufactured by Compumedics Limited. It received FDA 510(k) clearance on 2023-11-30 under approval number K231546. 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?

Somfit is a medical device that received FDA 510(k) clearance on 2023-11-30. It is manufactured by Compumedics Limited. The 510(k) number is K231546.

When was Somfit approved by the FDA?

Somfit received FDA 510(k) clearance on 2023-11-30, under approval number K231546.

What company makes Somfit?

Somfit is manufactured by Compumedics Limited.

What is the FDA product code for Somfit?

The FDA product code for Somfit is MNR.

Other Devices by Compumedics Limited

K191785Orion LifeSpan MEG K230073Okti K252383Somfit D 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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