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FDA 510(k)

Silk Voice

K-Number: K180631 · 2018-11-08

ApplicantSofregen Medical, Inc.
Decision Date2018-11-08
Product CodeMIX
Advisory CommitteeEN
DecisionSubstantially Equivalent

Device Summary

Silk Voice is a medical device manufactured by Sofregen Medical, Inc.. It received FDA 510(k) clearance on 2018-11-08 under approval 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. It is manufactured by Sofregen Medical, Inc.. The 510(k) number is K180631.

When was Silk Voice approved by the FDA?

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

What company makes Silk Voice?

Silk Voice is manufactured by Sofregen Medical, Inc..

What is the FDA product code for Silk Voice?

The FDA product code for Silk Voice is MIX.

Other Devices by Sofregen Medical, Inc.

K172545SERI Contour

Related Devices (Code: MIX)

K240919Silk Voice (SMI-04)Sofregen Medical

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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