8100/8500 VITAL SIGNS MONITOR— 510(k) K012059

Name: FDA 510(k) clearance K012059
Creator: U.S. Food and Drug Administration
Published: 2001-08-01

Substantially Equivalent

Criticare Systems, Inc.

FDA 510(k) clearance K012059 for 8100/8500 VITAL SIGNS MONITOR, Substantially Equivalent on 2001-08-01. Applicant: Criticare Systems, Inc.. Device class: 2.

Clearance details

Applicant: Criticare Systems, Inc.
Product code: Code MWI
Device class: Class 2
Regulation: 21 CFR 870.2300
Advisory panel: Cardiovascular
Date received: 2001-07-02
Decision date: 2001-08-01
Decision: Substantially Equivalent
Clearance type: Special
Location: Waukesha, WI, US

Download summary PDF View on FDA.gov ↗

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K253436 — c-med0 alpha2026-04-30
K250135 — WAVE Clinical Platform (2.0.000)2026-01-16

More clearances from Criticare Systems, Inc.

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K101602 — VITAL SIGNS MONITOR2010-09-01
K091050 — 506CN PATIENT MONITOR2009-05-27
K042569 — 8600 VITAL SIGNS MONITOR2004-09-29
K030613 — VITAL SIGNS MONITOR W/ARRHYTHMIA DETECTION AND ST ANALYSIS, MODEL 81002003-04-17
K022435 — 507EL VITAL SIGNS MONITOR2002-08-14

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.