K242717
- 510(k) number
- K242717
- Device name
- Laboratorios Biogalenic Sterile Water for Inhalation, USP
- Applicant
- Laboratorios Biogalenic S.A. DE C.V. SV
- Product code
- BTT — Humidifier, Respiratory Gas, (Direct Patient Interfa
- Decision date
- 2025-01-30
- Date received
- 2024-09-10
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Anesthesiology
PDFDownload 510(k) SummaryArchived here · 0.7 MB · U.S. public domain
Also available from FDA: K242717.pdf
Official FDA record: K242717
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.