Reusable Full Silicone Cover— 510(k) K151702

Name: FDA 510(k) clearance K151702
Creator: U.S. Food and Drug Administration
Published: 2015-08-13

Substantially Equivalent

Laerdal Medical AS

FDA 510(k) clearance K151702 for Reusable Full Silicone Cover, Substantially Equivalent on 2015-08-13. Applicant: Laerdal Medical AS. Device class: 2.

Clearance details

Applicant: Laerdal Medical AS
Product code: Code LIX
Device class: Class 2
Regulation: 21 CFR 870.5210
Advisory panel: Cardiovascular
Date received: 2015-06-24
Decision date: 2015-08-13
Decision: Substantially Equivalent
Clearance type: Special
Location: Stavanger, NO

Download summary PDF View on FDA.gov ↗

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Adverse events under product code LIX

product code LIX

Other: 2
Total: 2

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.