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FDA 510(k)

Sonio Detect

K-Number: K230365 · 2023-07-25

ApplicantSonio
Decision Date2023-07-25
Product CodeIYN
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

Sonio Detect is a medical device manufactured by Sonio. It received FDA 510(k) clearance on 2023-07-25 under approval number K230365. The device is classified under product code IYN. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Sonio Detect?

Sonio Detect is a medical device that received FDA 510(k) clearance on 2023-07-25. It is manufactured by Sonio. The 510(k) number is K230365.

When was Sonio Detect approved by the FDA?

Sonio Detect received FDA 510(k) clearance on 2023-07-25, under approval number K230365.

What company makes Sonio Detect?

Sonio Detect is manufactured by Sonio.

What is the FDA product code for Sonio Detect?

The FDA product code for Sonio Detect is IYN.

Other Devices by Sonio

K240406Sonio Detect K243614Sonio Suspect K252433Sonio Detect (v3)

Related Devices (Code: IYN)

K162845DC-40/DC-35/DC-45/DC-40S/DC-40 Pro Diagnostic Ultrasound SystemShenzhen Mindray Bio-Medical Electronics Co., Ltd. K162902ARIETTA Prologue Diagnostic Ultrasound system and TransducersHitachi , Ltd. K163138Clarius Ultrasound SystemClarius Mobile Health Corp. K163077LOGIQ E9, LOGIQ E9 XDClear 2.0GE Medical Systems Ultrasound and Primary Care Diagnostics K162583ALOKA LISENDO 880Hitachi , Ltd. K163020Xperius Ultrasound SystemPhilips Health Care

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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