DeviceClearance

K981460

Substantially Equivalent

CUB DIS II DPOAE MEASUREMENT SYSTEM

Applicant
Mimosa Acoustics, Inc.
Product code
EWO
Advisory panel
Ear, Nose, Throat
Date received
Decision date
Decision
Substantially Equivalent
Clearance type
Traditional
Location
Mountainside, NJ, 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, through . 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.