PROFA— 510(k) K981911

Substantially Equivalent

Duncan Hynd Associates, Ltd.

FDA 510(k) clearance K981911 for PROFA, Substantially Equivalent on 1998-11-12. Applicant: Duncan Hynd Associates, Ltd..

Clearance details

Applicant: Duncan Hynd Associates, Ltd.
Product code: Code IYE
Advisory panel: Radiology
Date received: 1998-06-01
Decision date: 1998-11-12
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Teaneck, NJ, 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.