Modification of Apexpro Telemetry System
FDA 510(k) K021325 · General Electric Medical Systems Information Techn
510(k) numberK021325
Submission
- Device name
- Modification of Apexpro Telemetry System
- Applicant
- General Electric Medical Systems Information Techn
Milwaukee, WI, US - Received
- April 26, 2002
- Decision date
- May 7, 2002
- Decision
- Substantially Equivalent (SESE)
- Type
- Special 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- MHX – Monitor, Physiological, Patient(With Arrhythmia Detection Or Alarms)
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 870.1025
- Specialty
- Cardiovascular
Other 510(k)s with product code MHX
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|---|---|---|---|
| K260656 | Carescape ONE; Carescape Dock F0; TruSignal ECG MM; TruSignal PRES MM; TruSignal TEMP…MHX · Traditional | GE Healthcare Finland Oy | 09/01/2026SE |
| K260343 | Carescape Canvas 1000; Carescape Canvas Smart DisplayMHX · Traditional | GE Healthcare Finland Oy | 08/28/2026SE |
| K260579 | Infinity® Acute Care System (IACS) VG8.1MHX · Traditional | Draeger Medical Systems, Inc. | 08/20/2026SE |
| K251508 | Telemetry Monitor (iT30, iT50)MHX · Traditional | Edan Instruments, Inc. | 08/06/2026SE |
| K253277 | Monitor B105M; Monitor B125M; Monitor B155M; Monitor B105P; Monitor B125PMHX · Traditional | Ge Medical Systems Information Technologies, Inc. | 07/24/2026SE |
| K254209 | Radius VSM and AccessoriesMHX · Traditional | Masimo Corporation | 06/04/2026SE |
| K252840 | M12 Telemetry SystemMHX · Traditional | Global Instrumentation, LLC | 05/29/2026SE |
| K260098 | ePM Series Patient Monitor (ePM 10/ePM 10A/ePM 10C/Guardian plus/ ePM 12/ePM 12A/ePM 12C…MHX · Traditional | Shenzhen Mindray Bio-Medical Electronics Co., Ltd. | 05/20/2026SE |
| K250349 | Vista CMSMHX · Traditional | Shanghai Draeger Medical Instrument Co., Ltd. | 04/24/2026SE |
| K253170 | uMEC 60/ uMEC 70/ uMEC 80/uMEC 100/uMEC 120/uMEC 150 Patient MonitorsMHX · Traditional | Shenzhen Mindray Bio-Medical Electronics Co., Ltd. | 04/16/2026SE |
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| K021454 | Unity Network IdMWI · Traditional | 10/01/2002SE |
| K020290 | Dash 3000/4000 Patient MonitorMHX · Traditional | 08/14/2002SE |
| K021366 | Mac-Lab/Cardiolab Ep/CombolabDQK · Special | 07/03/2002SE |
| K020661 | Unity Is Patient ViewerMSX · Traditional | 05/24/2002SE |
| K020524 | Patientnet Monitoring SystemMSX · Special | 03/20/2002SE |
| K012467 | Solar 8000M SystemDSI · Traditional | 02/11/2002SE |
| K014108 | Mac 5000 ECG Analysis SystemDQK · Special | 01/10/2002SE |
Questions and answers
When was Modification of Apexpro Telemetry System cleared by the FDA?
Modification of Apexpro Telemetry System (K021325) received a 510(k) decision of Substantially Equivalent on May 7, 2002, 11 days after the submission was received.
What is the product code of K021325?
The FDA product code is MHX – Monitor, Physiological, Patient(With Arrhythmia Detection Or Alarms), a Class II (moderate risk) device regulated under 21 CFR 870.1025.