510(k) K111614 ยท HGM System, Monitoring, Perinatal
CENTRICITY PERINATAL AND CENTRICITY INTENSIVE CARE
| Applicant | Ge Healthcare Integrated IT Solutions, Barrington IL, US |
| Decision | Substantially Equivalent, Sep 26, 2011 |
| Received | Jun 8, 2011 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K111614
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Nov 18, 2013 | GE Healthcare It Centricity Perinatal and Centricity Intensive Care is intended to be used in clinical departments healthcare delivery systems such as a Labor and Delivery, Postpartum Maternal Care, newborn Nursery, c Terminated |
HGM | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.