DeviceClearance

DIGITAL LGOB PROCEDURE USING RESOUND, DIGITAL 5000 SERIES HEARING AIDS— 510(k) K984547

Substantially Equivalent

Resound Corp.

FDA 510(k) clearance K984547 for DIGITAL LGOB PROCEDURE USING RESOUND, DIGITAL 5000 SERIES HEARING AIDS, Substantially Equivalent on 1999-03-19. Applicant: Resound Corp..

Clearance details

Applicant
Resound Corp.
Product code
Code EWO
Advisory panel
Ear, Nose, Throat
Date received
Decision date
Decision
Substantially Equivalent
Clearance type
Traditional
Location
Redwood City, CA, US
Download summary PDFView 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.