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510(k) K243598

Welch Allyn Connex® 360 (Multiple) by Welch Allyn, Inc.

K243598 is an FDA 510(k) premarket notification submitted by Welch Allyn, Inc. for the device "Welch Allyn Connex® 360 (Multiple)". The FDA issued a decision of Substantially Equivalent on July 13, 2025. Welch Allyn, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 13, 2025
Date Received
November 21, 2024
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Other clearances by Welch Allyn, Inc.

  • K241411 — Welch Allyn Connex® Spot Monitor; 901058 Vital Signs Monitor Core (CSM) (December 20, 2024)
  • K223381 — iExaminer System with Panoptic Plus (March 15, 2023)
  • K212473 — Welch Allyn Connex Central Station (October 28, 2022)
  • K191013 — Welch Allyn Diagnostic Cardiology Suite 2.X.X with Spirometry option (September 10, 2019)
  • K181016 — Welch Allyn RetinaVue Network REF 901108 PACS Medical Image System (July 16, 2018)
  • K171621 — Welch Allyn Connex Vital Signs Monitor, Welch Allyn Connex Integrated Wall Syste (June 30, 2017)
  • K142356 — Connex Spot Monitor,901058 Vital Signs Monitor Core (December 19, 2014)
  • K141582 — CP150 ELECTROCARDIOGRAPH WITH SPIROMETRY OPTION (July 11, 2014)
  • K132807 — MONITORING STATION, CONNEX(R) CENTRAL STATION (CS) (January 31, 2014)
  • K132808 — VITAL SIGNS MONITOR, CONNEX VITAL SIGNS MONITOR (November 20, 2013)

FDA data resources