Nonrulemaking

Requiring modifications to the following hemodialysis machines manufactured by Fresenius USA, Inc., in order to provide safer hemodialysis treatments for patients and consumers 2008K2 Hemodialysis Machines, cleared under 510(k) no. K153449; the 2008T Hemodialysis Machines, first cleared under 510(k) no. K173972. K080964; and the 2008T BlueStar Hemodialysis Machines, cleared under 510(k) no. K17397

Documents
2
Total comments
0
all analyzed
Comment status
Closed
Last activity
In this docket

Documents

Rules, notices, and supporting material — the primary rule pinned first.

📄 Primary document
OtherJul 20, 2026
Response Letter
No comment period
Open →