Welch Allyn Connex Vital Signs Monitor, Welch Allyn Connex Integrated Wall System, 901060 Vital Signs Monitor
FDA 510(k) K171621 · Welch Allyn, Inc.
510(k) numberK171621
Submission
- Device name
- Welch Allyn Connex Vital Signs Monitor, Welch Allyn Connex Integrated Wall System, 901060 Vital Signs Monitor
- Applicant
- Welch Allyn, Inc.
Skaneateles Falls, NY, US - Received
- June 2, 2017
- Decision date
- June 30, 2017
- 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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| 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 |
|---|---|---|
| K243598 | Welch Allyn Connex® 360 (Multiple) · Traditional | 07/13/2025SE |
| K241411 | Welch Allyn Connex® Spot Monitor; 901058 Vital Signs Monitor Core (CSM)MWI · Traditional | 12/20/2024SE |
| K223381 | iExaminer System with Panoptic PlusHKI · Traditional | 03/15/2023SE |
| K212473 | Welch Allyn Connex Central StationMWI · Traditional | 10/28/2022SE |
| K191013 | Welch Allyn Diagnostic Cardiology Suite 2.X.X with Spirometry optionBZG · Traditional | 09/10/2019SE |
| K181016 | Welch Allyn RetinaVue Network REF 901108 PACS Medical Image SystemNFJ · Traditional | 07/16/2018SE |
| K142356 | Connex Spot Monitor,901058 Vital Signs Monitor CoreMWI · Traditional | 12/19/2014SE |
| K141582 | CP150 Electrocardiograph with Spirometry OptionDPS · Special | 07/11/2014SE |
| K132807 | Monitoring Station, Connex(R) Central Station (CS)MWI · Special | 01/31/2014SE |
| K132808 | Vital Signs Monitor, Connex Vital Signs MonitorMWI · Special | 11/20/2013SE |
Questions and answers
When was Welch Allyn Connex Vital Signs Monitor, Welch Allyn Connex Integrated Wall System, 901060 Vital Signs Monitor cleared by the FDA?
Welch Allyn Connex Vital Signs Monitor, Welch Allyn Connex Integrated Wall System, 901060 Vital Signs Monitor (K171621) received a 510(k) decision of Substantially Equivalent on June 30, 2017, 28 days after the submission was received.
What is the product code of K171621?
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.