510(k) K903143— OTOSCREENER-I AND OTO-SCREEN-I-P

Substantially Equivalent

Handtronix, Inc.

Clearance details

Applicant: Handtronix, Inc.
Product code: Code EWO
Advisory panel: Ear, Nose, Throat
Date received: 1990-07-18
Decision date: 1990-09-19
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Sandy, UT, US

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.