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FDA 510(k)

Silk Voice (SMI-04)

K-Number: K240919 · 2024-05-03

ApplicantSofregen Medical
Decision Date2024-05-03
Product CodeMIX
Advisory CommitteeEN
DecisionSubstantially Equivalent

Device Summary

Silk Voice (SMI-04) is a medical device manufactured by Sofregen Medical. It received FDA 510(k) clearance on 2024-05-03 under approval number K240919. The device is classified under product code MIX. It was reviewed by the EN advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Silk Voice (SMI-04)?

Silk Voice (SMI-04) is a medical device that received FDA 510(k) clearance on 2024-05-03. It is manufactured by Sofregen Medical. The 510(k) number is K240919.

When was Silk Voice (SMI-04) approved by the FDA?

Silk Voice (SMI-04) received FDA 510(k) clearance on 2024-05-03, under approval number K240919.

What company makes Silk Voice (SMI-04)?

Silk Voice (SMI-04) is manufactured by Sofregen Medical.

What is the FDA product code for Silk Voice (SMI-04)?

The FDA product code for Silk Voice (SMI-04) is MIX.

Related Devices (Code: MIX)

K180631Silk VoiceSofregen Medical, Inc.

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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