HEARID+TE TRANSIENT-EVOKED OTOACOUSTIC EMISSIONS ANALYZER— 510(k) K063338
Substantially EquivalentMimosa Acoustics, Inc.
FDA 510(k) clearance K063338 for HEARID+TE TRANSIENT-EVOKED OTOACOUSTIC EMISSIONS ANALYZER, Substantially Equivalent on 2007-01-04. Applicant: Mimosa Acoustics, Inc..
Clearance details
- Applicant
- Mimosa Acoustics, Inc.
- Product code
- Code EWO
- Advisory panel
- Ear, Nose, Throat
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Champaign, IL, US
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.