510(k) K040498— MYSHELL

Substantially Equivalent

Sedat S.A.

Clearance details

Applicant: Sedat S.A.
Product code: Code DTL
Advisory panel: Cardiovascular
Date received: 2004-02-26
Decision date: 2004-07-02
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Charlestown, MA, US

Adverse events under product code DTL

product code DTL

Malfunction: 770
Total: 770

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.