510(k) K072080 ยท LGZ Warmer, Thermal, Infusion Fluid
NORMOFLO IRRIGATION FLUID WARMER, MODELS H-1100, H-1129, NORMOFLO IRRIGATION WARMING SET, MODELS, IR-40, IR-500, IR-600,
| Applicant | Smiths Medical Asd, Inc., Rockland MA, US |
| Decision | Substantially Equivalent, Jun 2, 2008 |
| Received | Jul 30, 2007 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K072080
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Aug 6, 2021 | Smiths Medical ASD Inc. NORMOFLO Irrigation Fluid Warmer Models H-1100 and H-1129 Open, Classified |
LGZ | None listed |
| Aug 6, 2021 | Smiths Medical ASD Inc. NORMOFLO Irrigation Warming administration set (disposable), Models IR-40, IR-500, IR-600, IRI-600, IRI-600B, IR-700 Open, Classified |
LGZ | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.