FDA 510(k)

Silk Voice (SMI-04)

K-Number: K240919 · 2024-05-03

Decision Date2024-05-03

Product CodeMIX

Advisory CommitteeEN

DecisionSubstantially Equivalent

Device Summary

Silk Voice (SMI-04) is the device name listed in this FDA 510(k) record. The listed applicant is Sofregen Medical. It received FDA 510(k) clearance on 2024-05-03 under 510(k) 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. The listed applicant is Sofregen Medical. The 510(k) number is K240919.

When did Silk Voice (SMI-04) receive FDA 510(k) clearance?

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

Who is the listed applicant for Silk Voice (SMI-04)?

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

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

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

Other records listing Sofregen Medical 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.

K180631Silk Voice K172545SERI Contour

Related Devices (Code: MIX)

K180631Silk VoiceSofregen Medical, Inc.

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.