VITAL SIGNS MONITOR-VSM 6000 SERIES— 510(k) K101445

Name: FDA 510(k) clearance K101445
Creator: U.S. Food and Drug Administration
Published: 2010-06-08

Substantially Equivalent

Welch Allyn, Inc.

FDA 510(k) clearance K101445 for VITAL SIGNS MONITOR-VSM 6000 SERIES, Substantially Equivalent on 2010-06-08. Applicant: Welch Allyn, Inc.. Device class: 2.

Clearance details

Applicant: Welch Allyn, Inc.
Product code: Code MWI
Device class: Class 2
Regulation: 21 CFR 870.2300
Advisory panel: Cardiovascular
Date received: 2010-05-24
Decision date: 2010-06-08
Decision: Substantially Equivalent
Clearance type: Abbreviated
Location: Skaneateles Falls, NY, US

Download summary PDF View on FDA.gov ↗

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K250135 — WAVE Clinical Platform (2.0.000)2026-01-16

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K191013 — Welch Allyn Diagnostic Cardiology Suite 2.X.X with Spirometry option2019-09-10

Adverse events under product code MWI

product code MWI

Death: 16
Malfunction: 963
Total: 979

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

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