510(k) K041163 ยท FIP Subsystem, Water Purification
ISOPURE COMPLETE WATER SYSTEM FOR HEMODIALYSIS, MD 400 AND MD 600 SERIES
| Applicant | Isopure, Corp., Simpsonville KY, US |
| Decision | Substantially Equivalent, Oct 7, 2004 |
| Received | May 3, 2004 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K041163
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Nov 16, 2011 | Isopure Corp Step 2, 3000-22000 GPD (Sodium Hydroxide 2.0N) cleaning solution. 4 oz plastic bottle. Lot # 11IC002, Serial #'s: 11IC00210 - 11IC002294.
The Step 2, 3000-2000 GPD chemical is used in the cleaning Terminated |
KPO | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.