Mr. Gan · haixiao@sungolytest.com · +86 158 2169 5110 · +86 132 4819 8029Mr. Luo · jun.luo@sungoglobal.com · +86 177 5560 4650

K230665

Dose IQ Safety Software

510(k) number
K230665
Device name
Dose IQ Safety Software
Applicant
Baxter Healthcare Corporation IL · US
Product code
PHC — Infusion Safety Management Software
Decision date
2024-03-29
Date received
2023-03-10
Decision
Substantially Equivalent
Clearance type
Traditional
Advisory committee
General Hospital
510(k) Summary (official FDA PDF): K230665.pdf
Official FDA record: K230665
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.