SEDAT MYSHELL LITE— 510(k) K080472

Name: FDA 510(k) clearance K080472
Creator: U.S. Food and Drug Administration
Published: 2008-04-23

Substantially Equivalent

Sedat

FDA 510(k) clearance K080472 for SEDAT MYSHELL LITE, Substantially Equivalent on 2008-04-23. Applicant: Sedat. Device class: 2.

Clearance details

Applicant: Sedat
Product code: Code DTL
Device class: Class 2
Regulation: 21 CFR 870.4290
Advisory panel: Cardiovascular
Date received: 2008-02-21
Decision date: 2008-04-23
Decision: Substantially Equivalent
Clearance type: Special
Location: San Diego, CA, US

Download summary PDF View on FDA.gov ↗

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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.