POD PAC-20M— 510(k) K030610

Substantially Equivalent

Portable Ophthalmic Devices, Inc.

FDA 510(k) clearance K030610 for POD PAC-20M, Substantially Equivalent on 2003-03-21. Applicant: Portable Ophthalmic Devices, Inc..

Clearance details

Applicant: Portable Ophthalmic Devices, Inc.
Product code: Code IYO
Advisory panel: Radiology
Date received: 2003-02-26
Decision date: 2003-03-21
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Bettendorf, IA, US

Download summary PDF View on FDA.gov ↗

Adverse events under product code IYO

product code IYO

Malfunction: 3,339
Total: 3,339

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.