FDA 510(k)

Vave Personal Ultrasound System

K-Number: K191541 · 2019-07-10

Decision Date2019-07-10

Product CodeIYO

Advisory CommitteeRA

DecisionSubstantially Equivalent

Device Summary

Vave Personal Ultrasound System is the device name listed in this FDA 510(k) record. The listed applicant is Vave Health, Inc.. It received FDA 510(k) clearance on 2019-07-10 under 510(k) number K191541. The device is classified under product code IYO. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Vave Personal Ultrasound System?

Vave Personal Ultrasound System is a medical device that received FDA 510(k) clearance on 2019-07-10. The listed applicant is Vave Health, Inc.. The 510(k) number is K191541.

When did Vave Personal Ultrasound System receive FDA 510(k) clearance?

Vave Personal Ultrasound System received FDA 510(k) clearance on 2019-07-10, under 510(k) number K191541.

Who is the listed applicant for Vave Personal Ultrasound System?

The FDA 510(k) record lists Vave Health, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Vave Personal Ultrasound System?

The FDA product code for Vave Personal Ultrasound System is IYO.

Other records listing Vave Health, Inc. 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.