FDA 510(k)

SONON Ultrasound Imaging System, Model: SONON300C

K-Number: K211665 · 2022-05-16

Decision Date2022-05-16

Product CodeIYN

Advisory CommitteeRA

DecisionSubstantially Equivalent

Device Summary

SONON Ultrasound Imaging System, Model: SONON300C is the device name listed in this FDA 510(k) record. The listed applicant is Healcerion Co., Ltd.. It received FDA 510(k) clearance on 2022-05-16 under 510(k) number K211665. 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 SONON Ultrasound Imaging System, Model: SONON300C?

SONON Ultrasound Imaging System, Model: SONON300C is a medical device that received FDA 510(k) clearance on 2022-05-16. The listed applicant is Healcerion Co., Ltd.. The 510(k) number is K211665.

When did SONON Ultrasound Imaging System, Model: SONON300C receive FDA 510(k) clearance?

SONON Ultrasound Imaging System, Model: SONON300C received FDA 510(k) clearance on 2022-05-16, under 510(k) number K211665.

Who is the listed applicant for SONON Ultrasound Imaging System, Model: SONON300C?

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

What is the FDA product code for SONON Ultrasound Imaging System, Model: SONON300C?

The FDA product code for SONON Ultrasound Imaging System, Model: SONON300C is IYN.

Other records listing Healcerion 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.

K212400SONON Ultrasound Imaging System, Model: SONON 500L K170085SONON Ultrasound Imaging System, Model: 300L

Related Devices (Code: IYN)

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.