510(k) K963608 ยท HGM System, Monitoring, Perinatal
QUANTITATIVE SENTINEL SYSTEM
| Applicant | Quantitative Medicine, Inc., Wallingford CT, US |
| Decision | Substantially Equivalent, Mar 11, 1997 |
| Received | Sep 10, 1996 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K963608
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.