510(k) K912138 ยท HGM System, Monitoring, Perinatal
HOMEVUE MONITORING SYS.MODEL TD 2000
| Applicant | Homevue Health Systems, Inc., Laguna Beach CA, US |
| Decision | Substantially Equivalent, Mar 19, 1992 |
| Received | May 14, 1991 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K912138
No recall in the FDA data names this 510(k).
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.