510(k) K212473

Welch Allyn Connex Central Station by Welch Allyn, Inc. — Product Code MWI

K212473 is an FDA 510(k) premarket notification submitted by Welch Allyn, Inc. for the device "Welch Allyn Connex Central Station". The FDA issued a decision of Substantially Equivalent on October 28, 2022. The device falls under product code MWI (Monitor, Physiological, Patient (Without Arrhythmia Detection Or Alarms)), a Class II device regulated under 21 CFR 870.2300. Welch Allyn, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 28, 2022
Date Received
August 6, 2021
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Monitor, Physiological, Patient (Without Arrhythmia Detection Or Alarms)
Device Class
Class II
Regulation Number
870.2300
Review Panel
CV
Submission Type