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FDA 510(k)

Vave Personal Ultrasound System

K-Number: K191541 · 2019-07-10

ApplicantVave Health, Inc.
Decision Date2019-07-10
Product CodeIYO
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

Vave Personal Ultrasound System is a medical device manufactured by Vave Health, Inc.. It received FDA 510(k) clearance on 2019-07-10 under approval 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. It is manufactured by Vave Health, Inc.. The 510(k) number is K191541.

When was Vave Personal Ultrasound System approved by the FDA?

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

What company makes Vave Personal Ultrasound System?

Vave Personal Ultrasound System is manufactured by Vave Health, Inc..

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

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

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Other Devices by Vave Health, Inc.

K241051Vave Wireless Ultrasound System

Related Devices (Code: IYO)

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Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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