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

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..

Clearance details

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

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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.