510(k) K133175 ยท MQM Bilirubin (Total And Unbound) In The Neonate Test System
DRAEGER JAUNDICE METER JM-105
| Applicant | Draeger Medical Systems, Inc., Telford PA, US |
| Decision | Substantially Equivalent, Nov 13, 2014 |
| Received | Oct 17, 2013 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K133175
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Jun 7, 2018 | Draeger Medical Systems, Inc. Draeger Jaundice Meter JM-105
The device is intended for use in hospitals, clinics or doctor s offices under a physician s supervision / direction to assist clinicians in monitoring of newborn infant Terminated |
MQM | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.