510(k) K033365 ยท MHX Monitor, Physiological, Patient(With Arrhythmia Detection Or Alarms)
APEXPRO FH TELEMETRY SYSTEM
| Applicant | Ge Medical Systems Information Technologies, Milwaukee WI, US |
| Decision | Substantially Equivalent, Nov 6, 2003 |
| Received | Oct 21, 2003 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K033365
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Nov 12, 2019 | GE Healthcare, LLC ApexPro Telemetry System - Product Usage: The ApexPro Telemetry System is intended for use under the direct supervision of a licensed healthcare practitioner. The system is designed to acquire and mon Terminated |
DSI | None listed |
| Oct 23, 2019 | GE Healthcare, LLC ApexPro Telemetry Server System. Also identified as Modification To: ApexPro Telemetry System and ApexPro FH Telemetry System - Product Usage: These systems are typically deployed in sub acute care a Open, Classified |
DSI | None listed |
| Oct 21, 2006 | Ge Healthcare ApexPro FH Telemetry System: composed of six major components (as follows); Accessories to the patient worn acquisition transceivers, the patient worn data acquisition transceivers, the transceiver ac Terminated |
MHX | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.