510(k) K913658 ยท MEB Pump, Infusion, Elastomeric
IMED 4100 AND 4200 DISPOSABLE INFUSION DEVICES MOD
| Applicant | Imed Corp., San Diego CA, US |
| Decision | Substantially Equivalent, Mar 26, 1992 |
| Received | Jul 29, 1991 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K913658
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Apr 7, 2009 | Cardinal Health 303 dba Cardinal Health ReadyMed Elastomeric Ambulatory Pump, Model Numbers: R050050, R100100, R100200, R250050, R250100, and R250167.
Intended for self-administration of anti-microbial and antiviral agents. Terminated |
FRN | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.