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FDA 510(k)

Sonu

K-Number: K242214 · 2025-04-24

ApplicantSound Health Systems, Inc.
Decision Date2025-04-24
Product CodeQZC
Advisory CommitteeEN
DecisionSubstantially Equivalent

Device Summary

Sonu is a medical device manufactured by Sound Health Systems, Inc.. It received FDA 510(k) clearance on 2025-04-24 under approval number K242214. The device is classified under product code QZC. It was reviewed by the EN advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Sonu?

Sonu is a medical device that received FDA 510(k) clearance on 2025-04-24. It is manufactured by Sound Health Systems, Inc.. The 510(k) number is K242214.

When was Sonu approved by the FDA?

Sonu received FDA 510(k) clearance on 2025-04-24, under approval number K242214.

What company makes Sonu?

Sonu is manufactured by Sound Health Systems, Inc..

What is the FDA product code for Sonu?

The FDA product code for Sonu is QZC.

Other Devices by Sound Health Systems, Inc.

DEN230045Sonu

Related Devices (Code: QZC)

DEN230045SonuSound Health Systems, 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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