iHearTest— 510(k) K151025

Substantially Equivalent

Ihear Medical, Inc.

FDA 510(k) clearance K151025 for iHearTest, Substantially Equivalent on 2015-12-29. Applicant: Ihear Medical, Inc..

Clearance details

Applicant: Ihear Medical, Inc.
Product code: Code EWO
Advisory panel: Ear, Nose, Throat
Date received: 2015-04-16
Decision date: 2015-12-29
Decision: Substantially Equivalent
Clearance type: Traditional
Location: San Leandro, CA, US

Download summary PDF View on FDA.gov ↗

Adverse events under product code EWO

product code EWO

Other: 2
Total: 2

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.