Welch Allyn Diagnostic Cardiology Suite 2.X.X with Spirometry option— 510(k) K191013

Name: FDA 510(k) clearance K191013
Creator: U.S. Food and Drug Administration
Published: 2019-09-10

Substantially Equivalent

Welch Allyn, Inc.

FDA 510(k) clearance K191013 for Welch Allyn Diagnostic Cardiology Suite 2.X.X with Spirometry option, Substantially Equivalent on 2019-09-10. Applicant: Welch Allyn, Inc.. Device class: 2.

Clearance details

Applicant: Welch Allyn, Inc.
Product code: Code BZG
Device class: Class 2
Regulation: 21 CFR 868.1840
Advisory panel: Anesthesiology
Date received: 2019-04-17
Decision date: 2019-09-10
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Milwaukee, WI, US

Download summary PDF View on FDA.gov ↗

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Recalls naming K191013

K-number listed on FDA's recall record

Z-0324-2025 — Hillrom Welch Allyn Diagnostic Cardiology Suite (formerly Connex Cardio); Diagnostic spirometerClass II·Ongoing·Baxter Healthcare Corporation·20241011

Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K191013.

Data sourced from openFDA. This site is unofficial and independent of the FDA.