FDA 510(k)
Substantially Equivalent
🇺🇸 United States
Welch Allyn Connex® 360 (Multiple)
K Number: K243598
·
Decision Jul 13, 2025
Classifications
0
FEI Numbers
0
Registration Numbers
0
Same Product Code
0
Applicant Total
111
Review Days
234
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Basic Information
- Device Name
- Welch Allyn Connex® 360 (Multiple)
- K Number
- K243598
- Clearance Type
- Traditional
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Welch Allyn, Inc.
- Date Received
- November 21, 2024
- Decision Date
- July 13, 2025
- Advisory Committee
- Unknown
- Review Advisory Committee
- CV
- Third Party
- N
Other Clearances by Welch Allyn, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| 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 |
| K171621 | Welch Allyn Connex Vital Signs Monitor, Welch Allyn Connex Integrated Wall System, 901060 Vital Signs Monitor | Jun 30, 2017 | 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 |