LSU 2000 PORTABLE SUCTION UNIT— 510(k) K950698

Name: FDA 510(k) clearance K950698
Creator: U.S. Food and Drug Administration
Published: 1995-05-09

Substantially Equivalent

Laerdal Medical Corp.

FDA 510(k) clearance K950698 for LSU 2000 PORTABLE SUCTION UNIT, Substantially Equivalent on 1995-05-09. Applicant: Laerdal Medical Corp.. Device class: 2.

Clearance details

Applicant: Laerdal Medical Corp.
Product code: Code JCX
Device class: Class 2
Regulation: 21 CFR 878.4780
Advisory panel: General, Plastic Surgery
Date received: 1995-02-10
Decision date: 1995-05-09
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Armonk, NY, US

Download summary PDF View on FDA.gov ↗

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Adverse events under product code JCX

product code JCX

Death: 11
Malfunction: 838
Other: 1
Total: 850

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.