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CBP

Valve, Non-Rebreathing

Product code
CBP
Device name
Valve, Non-Rebreathing
Device class
Class 2
21 CFR
21 CFR 868.5870
Medical specialty
Anesthesiology
Marketing pathway
510(K)
Flag
Life-sustaining / life-supporting
Flag
Third-party review eligible
510(k) clearances (last 3 years)
2
Summaries archived here
2 (direct download)
510(k) clearances (all years, FDA)
103 (all years; only the last 3 years are listed here)

510(k) clearances, last 3 years (2)

Last three years. Most recent: 2024-10-29.

NumberDecision dateApplicantDevice nameSummary
K2413662024-10-29Dehas Medical Systems GmbHQualityFlow O2 Series (QualityFLOW O2); QualityFlow …PDF
K2340532024-08-09Fisher & Paykel Healthcare, Ltd.F&P Optiflow Flow DiverterPDF

2 summaries are archived here for direct download.

Official FDA classification page: CBP
Classification and pathway per current FDA publications. Data from openFDA (CC0).