Device type
Humidifier, Respiratory Gas, (Direct Patient Interface)
Product code BTT · Class II · 21 CFR 868.5450 · Anesthesiology
Recent 510(k)s
Aug 27, 2026
K262268
Optiflow Oxygen Kit (AA484J)
Fisher and Paykel Healthcare Limited
- BTT
- Class II
Recent recalls
Sep 2, 2026
Z-2991-2026
Medline Hudson RCI, DBD-CIRCUIT,VENT,INSPIRATORY,HEATED,NEO, Medline Product Number/SKU HUD78019 (Teleflex Product Number/SKU 780-19); breathing circuit. Respi…
Medline Industries, LP
- BTT
- Class II
- Ongoing