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 the device name listed in this FDA 510(k) record. The listed applicant is Sound Health Systems, Inc.. It received FDA 510(k) clearance on 2025-04-24 under 510(k) 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. The listed applicant is Sound Health Systems, Inc.. The 510(k) number is K242214.
When did Sonu receive FDA 510(k) clearance?
Sonu received FDA 510(k) clearance on 2025-04-24, under 510(k) number K242214.
Who is the listed applicant for Sonu?
The FDA 510(k) record lists Sound Health Systems, Inc. as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for Sonu?
The FDA product code for Sonu is QZC.
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.