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FDA PRODUCT CODE · CLASS II

ONW — Hemodialysis System For Home Use

To treat and provide hemodialysis therapy at home for chronic renal failure patients.

DEVICE CLASS
Class II
REGULATION
21 CFR 876.5860
MEDICAL SPECIALTY
Gastroenterology, Urology
REVIEW PANEL
GU
— Implant— Life-sustaining— GMP-exempt— Third-party review eligible
1
510(K)/PMA CLEARANCES
510k: 1
0
RECALL ENTRIES

Recent clearances

K242269Quanta Dialysis Technologies, Ltd. · 510k2024-11-01

Related on SPEQ

Medical devices industry →Medical device quality (ISO 13485) →FDA device clearances →FDA enforcement & recalls →

Source: FDA device classification, 510(k)/PMA, and recall datasets (openFDA). Recall entries count distinct FDA recall numbers, so one recall event affecting several products appears as several entries. SPEQ is not affiliated with the FDA; this is a reference view of public FDA data.

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