LAERDAL SUCTION UNIT,(4000) MODEL 78 00 20— 510(k) K993668

Substantially Equivalent

Laerdal Medical A/S

FDA 510(k) clearance K993668 for LAERDAL SUCTION UNIT,(4000) MODEL 78 00 20, Substantially Equivalent on 1999-12-20. Applicant: Laerdal Medical A/S.

Clearance details

Applicant: Laerdal Medical A/S
Product code: Code BTA
Advisory panel: General, Plastic Surgery
Date received: 1999-11-01
Decision date: 1999-12-20
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Stavanger, NO

Download summary PDF View on FDA.gov ↗

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.