COMPACT OR COMP-X— 510(k) K972365

Substantially Equivalent

Eurotec, S.R.L.

FDA 510(k) clearance K972365 for COMPACT OR COMP-X, Substantially Equivalent on 1997-12-12. Applicant: Eurotec, S.R.L..

Clearance details

Applicant: Eurotec, S.R.L.
Product code: Code IZL
Advisory panel: Radiology
Date received: 1997-06-25
Decision date: 1997-12-12
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Scanzorosciate (Bg), IT

Download summary PDF View on FDA.gov ↗

Adverse events under product code IZL

product code IZL

Other: 3
Total: 3

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.