510(k) K042522 ยท MQM Bilirubin (Total And Unbound) In The Neonate Test System
JAUNDICE METER, MODEL JM 103
| Applicant | Draeger Medical Infant Care, Inc., Hatboro PA, US |
| Decision | Substantially Equivalent, Jul 6, 2005 |
| Received | Sep 16, 2004 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K042522
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Jun 7, 2018 | Draeger Medical Systems, Inc. Draeger Jaundice Meter JM-103
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 infan Terminated |
MQM | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.