510(k) K080251 ยท MHX Monitor, Physiological, Patient(With Arrhythmia Detection Or Alarms)
APEXPRO TELEMETRY SYSTEMS
| Applicant | Ge Medical Systems Information Technologies, Milwaukee WI, US |
| Decision | Substantially Equivalent, Jun 20, 2008 |
| Received | Jan 31, 2008 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K080251
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| May 28, 2026 | GE Medical Systems Information Technologies Inc GE HealthCare CARESCAPE TELEMETRY SERVER V5 ATO MODEL, REF #2063702-101, Product Code SS9; used in conjunction with ApexPro CARESCAPE Telemetry Server (CTS) v5.0; Monitor, Physiological, Patient(With Open, Classified |
MHX | None listed |
| 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 |
| Mar 3, 2011 | GE Healthcare, LLC GE Healthcare, ApexPro Telemetry System
The ApexPro Telemetry System is intended for use under the direct supervision of a licensed healthcare practitioner. The system is designed to acquire and moni Terminated |
MHX | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.