510(k) K052707 ยท MHX Monitor, Physiological, Patient(With Arrhythmia Detection Or Alarms)
M3046B COMPACT PORTABLE PATIENT MONITORS
| Applicant | Philips Medical Systems, Andover MA, US |
| Decision | Substantially Equivalent, Oct 20, 2005 |
| Received | Sep 29, 2005 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K052707
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Sep 16, 2008 | Philips Medical Systems Phillips Medical Systems, SureSigns VS3 Vital Signs Monitor model numbers 863071, 863072, 863073, 863074. All four model numbers have the same user manual. The device is intended for monitoring, reco Terminated |
MHX | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.