NOVAC7— 510(k) K990209

Substantially Equivalent

Hitesys S.P.A.

FDA 510(k) clearance K990209 for NOVAC7, Substantially Equivalent on 2000-06-22. Applicant: Hitesys S.P.A..

Clearance details

Applicant: Hitesys S.P.A.
Product code: Code IYE
Advisory panel: Radiology
Date received: 1999-01-21
Decision date: 2000-06-22
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Williamsburg, VA, 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.