GOODKNIGHT H20, MODEL M-114600-00— 510(k) K042184

Substantially Equivalent

Mallinckrodt Developpement France

FDA 510(k) clearance K042184 for GOODKNIGHT H20, MODEL M-114600-00, Substantially Equivalent on 2005-01-10. Applicant: Mallinckrodt Developpement France.

Clearance details

Applicant: Mallinckrodt Developpement France
Product code: Code BTT
Advisory panel: Anesthesiology
Date received: 2004-08-12
Decision date: 2005-01-10
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Villers-Les-Nancy Cedex, FR

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Adverse events under product code BTT

product code BTT

Death: 60
Injury: 152
Malfunction: 7,232
Other: 2
Total: 7,446

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.