Cleared Traditional

Welch Allyn Diagnostic Cardiology Suite 2.X.X with Spirometry option

K191013 · Welch Allyn, Inc. · Anesthesiology
Sep 2019
Decision
146d
Days
Class 2
Risk

About This 510(k) Submission

K191013 is an FDA 510(k) clearance for the Welch Allyn Diagnostic Cardiology Suite 2.X.X with Spirometry option, a Spirometer, Diagnostic (Class II — Special Controls, product code BZG), submitted by Welch Allyn, Inc. (Milwaukee, US). The FDA issued a Cleared decision on September 10, 2019, 146 days after receiving the submission on April 17, 2019. This device falls under the Anesthesiology review panel. Regulated under 21 CFR 868.1840.

Submission Details

510(k) Number K191013 FDA.gov
FDA Decision Cleared SESE
Date Received April 17, 2019
Decision Date September 10, 2019
Days to Decision 146 days
Submission Type Traditional
Review Panel Anesthesiology (AN)
Summary Summary PDF

Device Classification

Product Code BZG — Spirometer, Diagnostic
Device Class Class II — Special Controls
CFR Regulation 21 CFR 868.1840