FDA 510(k)

Silk Voice

K-Number: K180631 · 2018-11-08

Decision Date2018-11-08

Product CodeMIX

Advisory CommitteeEN

DecisionSubstantially Equivalent

Device Summary

Silk Voice is the device name listed in this FDA 510(k) record. The listed applicant is Sofregen Medical, Inc.. It received FDA 510(k) clearance on 2018-11-08 under 510(k) number K180631. 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?

Silk Voice is a medical device that received FDA 510(k) clearance on 2018-11-08. The listed applicant is Sofregen Medical, Inc.. The 510(k) number is K180631.

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

Silk Voice received FDA 510(k) clearance on 2018-11-08, under 510(k) number K180631.

Who is the listed applicant for Silk Voice?

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

What is the FDA product code for Silk Voice?

The FDA product code for Silk Voice is MIX.

Other records listing Sofregen Medical, Inc. 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.

K240919Silk Voice (SMI-04)K172545SERI Contour

Related Devices (Code: MIX)

K240919Silk Voice (SMI-04)Sofregen Medical

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.