510(k) K964340— PORTAREM-3000, PFS-6000

Substantially Equivalent

Starkey Laboratories, Inc.

Clearance details

Applicant: Starkey Laboratories, Inc.
Product code: Code EWO
Advisory panel: Ear, Nose, Throat
Date received: 1996-10-31
Decision date: 1997-01-10
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Eden Prairie, MN, 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.