OLDELFT DIGIDELCA— 510(k) K980296

Substantially Equivalent

Oldelft Corp. of America

FDA 510(k) clearance K980296 for OLDELFT DIGIDELCA, Substantially Equivalent on 1998-04-17. Applicant: Oldelft Corp. of America.

Clearance details

Applicant: Oldelft Corp. of America
Product code: Code KPR
Advisory panel: Radiology
Date received: 1998-01-27
Decision date: 1998-04-17
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Columbia, MD, US

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Adverse events under product code KPR

product code KPR

Other: 6
Total: 6

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.