DRY

Monitor, Blood-Gas, On-Line, Cardiopulmonary Bypass

Product code
DRY
Device name
Monitor, Blood-Gas, On-Line, Cardiopulmonary Bypass
Device class
Class 2
21 CFR
21 CFR 870.4330
Medical specialty
Cardiovascular
Marketing pathway
510(K)
Flag
Third-party review eligible
510(k) clearances (last 3 years)
1
Summaries archived here
1 (direct download)
510(k) clearances (all years, FDA)
47 (all years; only the last 3 years are listed here)

510(k) clearances, last 3 years (1)

Last three years. Most recent: 2024-04-25.

NumberDecision dateApplicantDevice nameSummary
K2340652024-04-25Terumo Cardiovascular Systems Corporat…CDI OneView Monitoring SystemPDF

1 summaries are archived here for direct download.

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