FDA 510(k)

Clarius OB AI

K-Number: K233955 · 2024-06-14

Decision Date2024-06-14

Product CodeIYN

Advisory CommitteeRA

DecisionSubstantially Equivalent

Device Summary

Clarius OB AI 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 2024-06-14 under 510(k) number K233955. 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 OB AI?

Clarius OB AI is a medical device that received FDA 510(k) clearance on 2024-06-14. The listed applicant is Clarius Mobile Health Corp.. The 510(k) number is K233955.

When did Clarius OB AI receive FDA 510(k) clearance?

Clarius OB AI received FDA 510(k) clearance on 2024-06-14, under 510(k) number K233955.

Who is the listed applicant for Clarius OB AI?

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 OB AI?

The FDA product code for Clarius OB AI 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.