FDA 510(k)

Clarius Ultrasound Scanner

K-Number: K192107 · 2019-08-29

Decision Date2019-08-29

Product CodeIYN

Advisory CommitteeRA

DecisionSubstantially Equivalent

Device Summary

Clarius Ultrasound Scanner is the device name listed in this FDA 510(k) record. The listed applicant is Clarius Mobile Health Corp.. It received FDA 510(k) clearance on 2019-08-29 under 510(k) number K192107. 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 Clarius Ultrasound Scanner?

Clarius Ultrasound Scanner is a medical device that received FDA 510(k) clearance on 2019-08-29. The listed applicant is Clarius Mobile Health Corp.. The 510(k) number is K192107.

When did Clarius Ultrasound Scanner receive FDA 510(k) clearance?

Clarius Ultrasound Scanner received FDA 510(k) clearance on 2019-08-29, under 510(k) number K192107.

Who is the listed applicant for Clarius Ultrasound Scanner?

The FDA 510(k) record lists Clarius Mobile Health Corp. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Clarius Ultrasound Scanner?

The FDA product code for Clarius Ultrasound Scanner is IYN.

Other records listing Clarius Mobile Health Corp. 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.