Cleared Traditional

Welch Allyn Connex Central Station

K212473 · Welch Allyn, Inc. · Cardiovascular

Oct 2022

Decision

448d

Days

Class 2

Risk

About This 510(k) Submission

K212473 is an FDA 510(k) clearance for the Welch Allyn Connex Central Station, a Monitor, Physiological, Patient (without Arrhythmia Detection Or Alarms) (Class II — Special Controls, product code MWI), submitted by Welch Allyn, Inc. (Skaneateles Falls, US). The FDA issued a Cleared decision on October 28, 2022, 448 days after receiving the submission on August 6, 2021. This device falls under the Cardiovascular review panel. Regulated under 21 CFR 870.2300.

Submission Details

510(k) Number	K212473 FDA.gov
FDA Decision	Cleared SESE
Date Received	August 06, 2021
Decision Date	October 28, 2022
Days to Decision	448 days
Submission Type	Traditional
Review Panel	Cardiovascular (CV)
Summary	Summary PDF

Device Classification

Product Code	MWI — Monitor, Physiological, Patient (without Arrhythmia Detection Or Alarms)
Device Class	Class II — Special Controls
CFR Regulation	21 CFR 870.2300