FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
Welch Allyn Connex Vital Signs Monitor, Welch Allyn Connex Integrated Wall System, 901060 Vital Signs Monitor
K Number: K171621
·
Decision Jun 30, 2017
Classifications
1
FEI Numbers
121
Registration Numbers
121
Same Product Code
424
Applicant Total
111
Review Days
28
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Basic Information
- Device Name
- Welch Allyn Connex Vital Signs Monitor, Welch Allyn Connex Integrated Wall System, 901060 Vital Signs Monitor
- K Number
- K171621
- Device Class
- FDA class 2
- Clearance Type
- Special
- Regulation Number
- 870.1025
- Medical Specialty
- Cardiovascular
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Welch Allyn, Inc.
- Date Received
- June 2, 2017
- Decision Date
- June 30, 2017
- Product Code
- MHX
- Advisory Committee
- Cardiovascular
- Review Advisory Committee
- CV
- Third Party
- N
Classifications
This FDA 510(k) entry is associated with 1 FDA classification via its product code.
| Product Code | Device Name | Device Class | Medical Specialty |
|---|---|---|---|
| MHX | Monitor, Physiological, Patient(With Arrhythmia Detection Or Alarms) | FDA class 2 | Cardiovascular |
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Other Clearances by Welch Allyn, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K243598 | Welch Allyn Connex® 360 (Multiple) | Jul 13, 2025 | Substantially Equivalent |
| K241411 | Welch Allyn Connex® Spot Monitor; 901058 Vital Signs Monitor Core (CSM) | Dec 20, 2024 | Substantially Equivalent |
| K223381 | iExaminer System with Panoptic Plus | Mar 15, 2023 | Substantially Equivalent |
| K212473 | Welch Allyn Connex Central Station | Oct 28, 2022 | Substantially Equivalent |
| K191013 | Welch Allyn Diagnostic Cardiology Suite 2.X.X with Spirometry option | Sep 10, 2019 | Substantially Equivalent |
| K181016 | Welch Allyn RetinaVue Network REF 901108 PACS Medical Image System | Jul 16, 2018 | Substantially Equivalent |
| K142356 | Connex Spot Monitor,901058 Vital Signs Monitor Core | Dec 19, 2014 | Substantially Equivalent |
| K132807 | MONITORING STATION, CONNEX(R) CENTRAL STATION (CS) | Jan 31, 2014 | Substantially Equivalent |
| K132808 | VITAL SIGNS MONITOR, CONNEX VITAL SIGNS MONITOR | Nov 20, 2013 | Substantially Equivalent |
| K131573 | CP150 ELECTROCARDIOGRAPH | Jul 3, 2013 | Substantially Equivalent |