510(k) K200494 ยท MHX Monitor, Physiological, Patient(With Arrhythmia Detection Or Alarms)
CARESCAPE ONE and CARESCAPE DOCK FO, CARESCAPE ECG, CARESCAPE TEMP, CARESCAPE PRES
| Applicant | GE Healthcare, Milwaukee WI, US |
| Decision | Substantially Equivalent, Mar 29, 2020 |
| Received | Feb 28, 2020 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K200494
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Aug 4, 2020 | GE Healthcare, LLC CARESCAPE ONE, Physiological Patient Monitor - Product Usage: is both a multi-parameter physiological patient monitor and an accessory to a multi-parameter patient monitor intended for use in multiple Terminated |
MHX | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.