PRESS-MATE PM-2100 VITAL SIGN MONITOR— 510(k) K022537

Substantially Equivalent

Colin Medical Instruments Corp.

FDA 510(k) clearance K022537 for PRESS-MATE PM-2100 VITAL SIGN MONITOR, Substantially Equivalent on 2002-09-13. Applicant: Colin Medical Instruments Corp..

Clearance details

Applicant: Colin Medical Instruments Corp.
Product code: Code MWI
Advisory panel: Cardiovascular
Date received: 2002-08-01
Decision date: 2002-09-13
Decision: Substantially Equivalent
Clearance type: Traditional
Location: San Antonio, TX, US

Download summary PDF View on FDA.gov ↗

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.