APEXPRO TELEMETRY SYSTEMS— 510(k) K080251
Substantially EquivalentGe Medical Systems Information Technologies
FDA 510(k) clearance K080251 for APEXPRO TELEMETRY SYSTEMS, Substantially Equivalent on 2008-06-20. Applicant: Ge Medical Systems Information Technologies. Device class: 2.
Clearance details
- Applicant
- Ge Medical Systems Information Technologies
- Product code
- Code MHX
- Device class
- Class 2
- Regulation
- 21 CFR 870.1025
- Advisory panel
- Cardiovascular
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Milwaukee, WI, US
Recent devices under product code MHX
view allMore clearances from Ge Medical Systems Information Technologies
view allAdverse events under product code MHX
product code MHX- Death
- 580
- Injury
- 2,441
- Malfunction
- 12,655
- Other
- 3
- Total
- 15,679
Source: openFDA MAUDE database, through . Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →
Recalls naming K080251
K-number listed on FDA's recall record- Z-2242-2026 — 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 Arrhythmia Detection Or Alarms)
- Z-0725-2020 — 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 monitor physiological data for ambulating patients within a defined coverage area. The system processes this physiological data to detect various ECG arrhythmia events and select physiological parameter limit violations. The ApexPro Telemetry System is intended to be installed in the hospital or clinical environment in order to provide clinicians with patient physiological data, while allowing for patient mobility. These systems are typically deployed in sub acute care areas in hospitals or clinical sites where patient mobility can enhance the effectiveness of the medical procedures administered.
- Z-0175-2020 — 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 areas in hospitals or clinical sites where patient mobility can enhance the effectiveness of the medical procedures administered.
Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K080251.
Data sourced from openFDA. This site is unofficial and independent of the FDA.