510(k) K852608 ยท HGM System, Monitoring, Perinatal
SPECTRA 400 EXTENDED SURVEILLANCE & ALERT SYSTEM
| Applicant | Ge Medical Systems Information Technologies, Wallingford CT, US |
| Decision | Substantially Equivalent, Sep 27, 1985 |
| Received | Jun 19, 1985 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K852608
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.