Monitor B40
FDA 510(k) K133576 · Ge Medical Systems China Co., Ltd.
510(k) numberK133576
Submission
- Device name
- Monitor B40
- Applicant
- Ge Medical Systems China Co., Ltd.
Milwaukee, WI, US - Received
- November 20, 2013
- Decision date
- February 21, 2014
- 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 |
More from Shenzhen Mindray Bio-Medical Electronics Co., Ltd.
| 510(k) | Device | Decision |
|---|---|---|
| K171580 | Monitor B125, Monitor B105MHX · Traditional | 11/01/2017SE |
| K151063 | Monitor B40MHX · Special | 12/15/2015SE |
| K142288 | MAC 800 Resting ECG Analysis SystemDPS · Special | 12/03/2014SE |
| K130584 | Monitor B40MHX · Traditional | 06/26/2013SE |
| K122253 | Procare Monitor B20MHX · Special | 03/22/2013SE |
| K123238 | AchillesMUA · Traditional | 02/25/2013SE |
| K120598 | Procare Monitor B40MHX · Traditional | 07/19/2012SE |
| K103633 | AchillesMUA · Traditional | 05/11/2011SE |
| K102256 | GE Logiq I/E & Vivid E Compact Diagnostic UltrasoundIYN · Traditional | 10/05/2010SE |
| K102113 | GE Venue 40 Compact Diagnostic UltrasoundIYN · Traditional | 08/12/2010SE |
Questions and answers
When was Monitor B40 cleared by the FDA?
Monitor B40 (K133576) received a 510(k) decision of Substantially Equivalent on February 21, 2014, 93 days after the submission was received.
What is the product code of K133576?
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.