510(k) K010744 ยท JOW Sleeve, Limb, Compressible
FLOWTRON UNIVERSAL, MODEL AC600
| Applicant | Huntleigh Healthcare, Inc., Eatontown NJ, US |
| Decision | Substantially Equivalent, Mar 26, 2002 |
| Received | Mar 13, 2001 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K010744
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Dec 27, 2012 | Arjo, Inc. dba ArjoHuntleigh Flowtron Trio DVT Pump; an Rx intermittent pneumatic compression deep vein thrombosis pump; ArjoHuntleigh AB, Eslov, Sweden; Model 512003; a non-invasive prophylaxis system for reducing the incidence Terminated |
JOW | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.