FDA 510(k)

SONON Ultrasound Imaging System, Model: 300L

K-Number: K170085 · 2017-10-12

Decision Date2017-10-12

Product CodeIYN

Advisory CommitteeRA

DecisionSubstantially Equivalent

Device Summary

SONON Ultrasound Imaging System, Model: 300L 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 2017-10-12 under 510(k) number K170085. 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: 300L?

SONON Ultrasound Imaging System, Model: 300L is a medical device that received FDA 510(k) clearance on 2017-10-12. The listed applicant is Healcerion Co., Ltd.. The 510(k) number is K170085.

When did SONON Ultrasound Imaging System, Model: 300L receive FDA 510(k) clearance?

SONON Ultrasound Imaging System, Model: 300L received FDA 510(k) clearance on 2017-10-12, under 510(k) number K170085.

Who is the listed applicant for SONON Ultrasound Imaging System, Model: 300L?

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: 300L?

The FDA product code for SONON Ultrasound Imaging System, Model: 300L 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.

K211665SONON Ultrasound Imaging System, Model: SONON300C K212400SONON Ultrasound Imaging System, Model: SONON 500L

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.