510(k) K021325 ยท MHX Monitor, Physiological, Patient(With Arrhythmia Detection Or Alarms)
MODIFICATION OF APEXPRO TELEMETRY SYSTEM
| Applicant | General Electric Medical Systems Information Techn, Milwaukee WI, US |
| Decision | Substantially Equivalent, May 7, 2002 |
| Received | Apr 26, 2002 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K021325
| 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 |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.