510(k) K965008 ยท HGM System, Monitoring, Perinatal
BIRTHNET II PERINATAL PATIENT DATA MANAGEMENT SYSTEM
| Applicant | Spacelabs Medical, Inc., Hamden CT, US |
| Decision | Substantially Equivalent, Dec 16, 1997 |
| Received | Dec 16, 1996 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K965008
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Nov 1, 2005 | Spacelabs Medical Incorporated BirthNet OB Data Management System 91861 Terminated |
HGM | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.