ULTRASONIC BIOMETER/ PACHYMETER FOR OPHTHALMOLOGY, MODEL ODM 2100, 2200— 510(k) K063472

Substantially Equivalent

Meda , Ltd.

FDA 510(k) clearance K063472 for ULTRASONIC BIOMETER/ PACHYMETER FOR OPHTHALMOLOGY, MODEL ODM 2100, 2200, Substantially Equivalent on 2007-01-31. Applicant: Meda , Ltd..

Clearance details

Applicant: Meda , Ltd.
Product code: Code IYO
Advisory panel: Radiology
Date received: 2006-11-15
Decision date: 2007-01-31
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Cleveland, OH, 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.