Vave Personal Ultrasound System— 510(k) K191541

Substantially Equivalent

Vave Health, Inc.

FDA 510(k) clearance K191541 for Vave Personal Ultrasound System, Substantially Equivalent on 2019-07-10. Applicant: Vave Health, Inc..

Clearance details

Applicant: Vave Health, Inc.
Product code: Code IYO
Advisory panel: Radiology
Date received: 2019-06-11
Decision date: 2019-07-10
Decision: Substantially Equivalent
Clearance type: Traditional
Location: San Mateo, CA, US

Download summary PDF View on FDA.gov ↗

Adverse events under product code IYO

product code IYO

Malfunction: 3,339
Total: 3,339

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

Data sourced from openFDA. This site is unofficial and independent of the FDA.