510(k) K223606 · PHC Infusion Safety Management Software
LifeShield Infusion Safety Software Suite
| Applicant | Icu Medical, Inc., Lake Forest IL, US |
| Decision | Substantially Equivalent, Aug 24, 2023 |
| Received | Dec 2, 2022 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K223606
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| May 14, 2025 | ICU Medical, Inc. LifeShield Drug Library Management (DLM), LifeShield Infusion Safety Software SUite v2.1 and v2.2 Open, Classified |
PHC | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.