K251419

Substantially Equivalent

Laboratorios Biogalenic Sterile Water for Inhalation, USP

Applicant: Laboratorios Biogalenic S.A. DE C.V.
Product code: BTT
Advisory panel: Anesthesiology
Date received: 2025-05-07
Decision date: 2026-01-14
Decision: Substantially Equivalent
Clearance type: Traditional
Location: San Salvador, SV

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.