510(k) K143438 ยท JOW Sleeve, Limb, Compressible
Flowtron ACS900
| Applicant | Getinge (Suzhou) Co., Ltd., Suzhou, TW |
| Decision | Substantially Equivalent, Jun 23, 2015 |
| Received | Dec 2, 2014 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K143438
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Jun 26, 2017 | Arjo, Inc. dba ArjoHuntleigh ArjoHuntleigh Flowtron ACS900, medical pump, software V1.099
Device is used to prevent the occurrence of Deep Vein Thrombosis (DVT) in at-risk patients. The system must be used as part of a prescribe Terminated |
JOW | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.