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FDA 510(k)

Welch Allyn Connex® Spot Monitor; 901058 Vital Signs Monitor Core (CSM)

K-Number: K241411 · 2024-12-20

ApplicantWelch Allyn, Inc.
Decision Date2024-12-20
Product CodeMWI
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

Welch Allyn Connex® Spot Monitor; 901058 Vital Signs Monitor Core (CSM) is a medical device manufactured by Welch Allyn, Inc.. It received FDA 510(k) clearance on 2024-12-20 under approval number K241411. The device is classified under product code MWI. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Welch Allyn Connex® Spot Monitor; 901058 Vital Signs Monitor Core (CSM)?

Welch Allyn Connex® Spot Monitor; 901058 Vital Signs Monitor Core (CSM) is a medical device that received FDA 510(k) clearance on 2024-12-20. It is manufactured by Welch Allyn, Inc.. The 510(k) number is K241411.

When was Welch Allyn Connex® Spot Monitor; 901058 Vital Signs Monitor Core (CSM) approved by the FDA?

Welch Allyn Connex® Spot Monitor; 901058 Vital Signs Monitor Core (CSM) received FDA 510(k) clearance on 2024-12-20, under approval number K241411.

What company makes Welch Allyn Connex® Spot Monitor; 901058 Vital Signs Monitor Core (CSM)?

Welch Allyn Connex® Spot Monitor; 901058 Vital Signs Monitor Core (CSM) is manufactured by Welch Allyn, Inc..

What is the FDA product code for Welch Allyn Connex® Spot Monitor; 901058 Vital Signs Monitor Core (CSM)?

The FDA product code for Welch Allyn Connex® Spot Monitor; 901058 Vital Signs Monitor Core (CSM) is MWI.

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Related PubMed Literature

PMID: 41836285 A Case Study of AI-Enabled Software as a Medical Device Cleared by the FDA for Assessing Hemorrhage Risk Index (APPRAISE-HRI) after Trauma. NEJM AI (2025)

Other Devices by Welch Allyn, Inc.

K171621Welch Allyn Connex Vital Signs Monitor, Welch Allyn Connex Integrated Wall System, 901060 Vital Signs Monitor K181016Welch Allyn RetinaVue Network REF 901108 PACS Medical Image System K191013Welch Allyn Diagnostic Cardiology Suite 2.X.X with Spirometry option K212473Welch Allyn Connex Central Station K223381iExaminer System with Panoptic Plus K243598Welch Allyn Connex® 360 (Multiple)

View all 7 devices →

Related Devices (Code: MWI)

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Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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