KLARITY— 510(k) K022708

Substantially Equivalent

Larson Products, Inc.

FDA 510(k) clearance K022708 for KLARITY, Substantially Equivalent on 2002-11-12. Applicant: Larson Products, Inc..

Clearance details

Applicant: Larson Products, Inc.
Product code: Code IYE
Advisory panel: Radiology
Date received: 2002-08-14
Decision date: 2002-11-12
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Columbus, OH, US

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Adverse events under product code IYE

product code IYE

Malfunction: 455
Other: 3
Total: 458

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.