LAERDAL SUCTION UNIT— 510(k) K840110

Name: FDA 510(k) clearance K840110
Creator: U.S. Food and Drug Administration
Published: 1984-03-12

Substantially Equivalent

Laerdal Medical Corp.

FDA 510(k) clearance K840110 for LAERDAL SUCTION UNIT, Substantially Equivalent on 1984-03-12. Applicant: Laerdal Medical Corp.. Device class: 2.

Clearance details

Applicant: Laerdal Medical Corp.
Product code: Code BTA
Device class: Class 2
Regulation: 21 CFR 878.4780
Advisory panel: General, Plastic Surgery
Date received: 1984-01-10
Decision date: 1984-03-12
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Mchenry, IL, US

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Adverse events under product code BTA

product code BTA

Death: 5
Total: 5

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.