FDA 510(k)

SonoSync

K-Number: K241302 · 2024-08-23

Decision Date2024-08-23

Product CodeLLZ

Advisory CommitteeRA

DecisionSubstantially Equivalent

Device Summary

SonoSync is the device name listed in this FDA 510(k) record. The listed applicant is Samsung Medison Co., Ltd.. It received FDA 510(k) clearance on 2024-08-23 under 510(k) number K241302. The device is classified under product code LLZ. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the SonoSync?

SonoSync is a medical device that received FDA 510(k) clearance on 2024-08-23. The listed applicant is Samsung Medison Co., Ltd.. The 510(k) number is K241302.

When did SonoSync receive FDA 510(k) clearance?

SonoSync received FDA 510(k) clearance on 2024-08-23, under 510(k) number K241302.

Who is the listed applicant for SonoSync?

The FDA 510(k) record lists Samsung Medison Co., Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for SonoSync?

The FDA product code for SonoSync is LLZ.

Other records listing Samsung Medison Co., Ltd. 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.

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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.