510(k) K140783 ยท FRN Pump, Infusion
HALO AMBULATORY INFUSION SYSTEM
| Applicant | Zyno Medical, LLC, Natick MA, US |
| Decision | Substantially Equivalent, Oct 17, 2014 |
| Received | Mar 31, 2014 |
| Type | Abbreviated |
| FDA record | Open on fda.gov |
Recalls that name K140783
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Mar 28, 2024 | InfuTronix LLC Nimbus Administration Set;
Nimbus Flex;
Nimbus PainPro (a.k.a. Halo Ambulatory Infusion
System);
Catalog Number IT1025. Ambulatory Infusion Pump and components Open, Classified |
FRN | None listed |
| Mar 28, 2024 | InfuTronix LLC Nimbus II Infusion System;
Nimbus II PainPRO IT1053;
Nimbus II Flex IT1062;
Nimbus II Plus IT1078;
Nimbus II EpiD IT1124;
Nimbus II EMS IT1063;
Ambulatory Infusion Pump and components Open, Classified |
FRN | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.