Patient Monitor
FDA 510(k) K112190 · Mediana Co., Ltd.
510(k) numberK112190
Submission
- Device name
- Patient Monitor
- Applicant
- Mediana Co., Ltd.
Echo, OR, US - Received
- July 29, 2011
- Decision date
- November 9, 2011
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 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
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|---|---|---|---|
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| 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 |
More from Shenzhen Mindray Bio-Medical Electronics Co., Ltd.
| 510(k) | Device | Decision |
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| K200434 | V20, V20a, AVSM3 SNFDXN · Traditional | 10/09/2020SE |
| K170497 | V10DXN · Traditional | 12/15/2017SE |
| K160358 | DT-100FLL · Traditional | 02/24/2017SE |
| K152659 | V10DXN · Traditional | 08/25/2016SE |
| K110612 | FM20HGM · Traditional | 11/08/2011SE |
| K110630 | F10KNG · Traditional | 06/24/2011SE |
| K100225 | Pulse Oximeter Model P10DQA · Traditional | 02/09/2011SE |
| K100217 | Lucon M-Series Patient Monitor, Models M20 and M30MHX · Traditional | 06/08/2010SE |
| K051375 | Vital Signs MonitorDXN · Traditional | 07/28/2005SE |
Questions and answers
When was Patient Monitor cleared by the FDA?
Patient Monitor (K112190) received a 510(k) decision of Substantially Equivalent on November 9, 2011, 103 days after the submission was received.
What is the product code of K112190?
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.