Patient Monitor (RespArray)
FDA 510(k) K240320 · Edan Instruments, Inc.
510(k) numberK240320
Submission
- Device name
- Patient Monitor (RespArray)
- Applicant
- Edan Instruments, Inc.
Shenzhen, CN - Received
- February 2, 2024
- Decision date
- June 28, 2024
- 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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| 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 |
|---|---|---|
| K251508 | Telemetry Monitor (iT30, iT50)MHX · Traditional | 08/06/2026SE |
| K252463 | SE-1202 Series Electrocardiograph (Model: SE-1202, SE-1202E)DPS · Traditional | 07/02/2026SE |
| K251591 | Holter ECG and ABP system (HolterABP)DQK · Traditional | 02/09/2026SE |
| K251268 | Diagnostic Ultrasound System (Nano C5, Nano C5 EXP, Nano L12, and Nano L12 EXP)IYN · Traditional | 12/23/2025SE |
| K241882 | Fetal & Maternal Monitor (F15A, F15A Air)HGM · Traditional | 08/27/2025SE |
| K250179 | Patient Monitor (CX10, CX12, CX15, UX10, UX12, UX15)MHX · Traditional | 07/29/2025SE |
| K250214 | Acclarix AX8 Series Diagnostic Ultrasound System (Model: Acclarix AX7, Acclarix AX8…IYN · Traditional | 02/20/2025SE |
| K232786 | Stimulation System (PA series, PR series, S series and Q series)IPF · Traditional | 05/16/2024SE |
| K232962 | Patient Monitor (iX10, iX12, iX15)MHX · Traditional | 04/19/2024SE |
| K233038 | Vital Signs monitor, Model: iM3s, iM3As, iM3Bs, iHM3sMWI · Traditional | 03/08/2024SE |
Questions and answers
When was Patient Monitor (RespArray) cleared by the FDA?
Patient Monitor (RespArray) (K240320) received a 510(k) decision of Substantially Equivalent on June 28, 2024, 147 days after the submission was received.
What is the product code of K240320?
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.