510(k) K921085— PROGRAMMED AUDIOMETRIC DEVICE (PAD)/RECORS (PAR)

Substantially Equivalent

Hear-Well Technologies, Inc.

Clearance details

Applicant: Hear-Well Technologies, Inc.
Product code: Code EWO
Advisory panel: Ear, Nose, Throat
Date received: 1992-03-06
Decision date: 1992-05-15
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Guelph, CA

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.