Cleared Traditional

Welch Allyn Connex? 360 (Multiple)

K243598 · Welch Allyn, Inc. · Cardiovascular
Jul 2025
Decision
234d
Days
Risk

About This 510(k) Submission

K243598 is an FDA 510(k) clearance for the Welch Allyn Connex? 360 (Multiple), submitted by Welch Allyn, Inc. (Skaneateles Falls, US). The FDA issued a Cleared decision on July 13, 2025, 234 days after receiving the submission on November 21, 2024. This device falls under the Cardiovascular review panel.

Submission Details

510(k) Number K243598 FDA.gov
FDA Decision Cleared SESE
Date Received November 21, 2024
Decision Date July 13, 2025
Days to Decision 234 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary Summary PDF

Device Classification

Product Code
Device Class