Laboratorios Biogalenic Sterile Water for Inhalation, USP— 510(k) K251419
Substantially EquivalentLaboratorios Biogalenic S.A. DE C.V.
FDA 510(k) clearance K251419 for Laboratorios Biogalenic Sterile Water for Inhalation, USP, Substantially Equivalent on 2026-01-14. Applicant: Laboratorios Biogalenic S.A. DE C.V.. Device class: 2.
Clearance details
- Applicant
- Laboratorios Biogalenic S.A. DE C.V.
- Product code
- Code BTT
- Device class
- Class 2
- Regulation
- 21 CFR 868.5450
- Advisory panel
- Anesthesiology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- San Salvador, SV
Recent devices under product code BTT
view all- K262268 — Optiflow Oxygen Kit (AA484J)
- K254078 — HVT 2.0
- K251448 — FL-10000U Respiratory Humidifier
- K253479 — Optiflow Switch+ Filtered Nasal Interface with CO2 Sampling (AA042J)
- K250312 — Hudson RCI® Comfort Flo Nasal Cannula Premature, Infant; Hudson RCI® Comfort Flo Plus and Soft Plus Cannula Extra Small
More clearances from Laboratorios Biogalenic S.A. DE C.V.
view allAdverse events under product code BTT
product code BTT- Death
- 60
- Injury
- 152
- Malfunction
- 7,232
- Other
- 2
- Total
- 7,446
Source: openFDA MAUDE database, through . 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.