AL-2000 COMBINED BIOMETER AND PACHYMETER— 510(k) K012803

Substantially Equivalent

Tomey Corp.

FDA 510(k) clearance K012803 for AL-2000 COMBINED BIOMETER AND PACHYMETER, Substantially Equivalent on 2002-04-08. Applicant: Tomey Corp..

Clearance details

Applicant: Tomey Corp.
Product code: Code IYO
Advisory panel: Radiology
Date received: 2001-08-21
Decision date: 2002-04-08
Decision: Substantially Equivalent
Clearance type: Traditional
Location: North Reading, MA, 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.