DIR 800— 510(k) K202391

Substantially Equivalent

Aesculap, Inc.

FDA 510(k) clearance K202391 for DIR 800, Substantially Equivalent on 2021-01-21. Applicant: Aesculap, Inc..

Clearance details

Applicant: Aesculap, Inc.
Product code: Code IZI
Advisory panel: Radiology
Date received: 2020-08-21
Decision date: 2021-01-21
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Center Valley, PA, US

Download summary PDF View on FDA.gov ↗

Adverse events under product code IZI

product code IZI

Death: 9
Malfunction: 5,312
Total: 5,321

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.