FDA 510(k) Application Details - K243598

Device Classification Name

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510(K) Number K243598
Device Name Welch Allyn Connex« 360 (Multiple)
Applicant Welch Allyn, Inc.
4341 State Street Road
Skaneateles Falls, NY 13153 US
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Contact Susan Schmidt
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Regulation Number

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Classification Product Code
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Date Received 11/21/2024
Decision Date 07/13/2025
Decision SESE - SUBST EQUIV
Classification Advisory Committee -
Review Advisory Committee CV - Cardiovascular
Statement / Summary / Purged Status Summary
Type Traditional
Reviewed By Third Party N
Expedited Review

FDA Source Information for K243598


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