VITALMAX 4000 CONFIGURED/VITALMAX 4000 MODULAR/VITALMAX 4100/MINIPACK 3100/3000/VITALMAX 800+/MINIPACK 300— 510(k) K970445

Substantially Equivalent

Pace Tech Medical Monitors, Inc.

FDA 510(k) clearance K970445 for VITALMAX 4000 CONFIGURED/VITALMAX 4000 MODULAR/VITALMAX 4100/MINIPACK 3100/3000/VITALMAX 800+/MINIPACK 300, Substantially Equivalent on 1998-01-30. Applicant: Pace Tech Medical Monitors, Inc..

Clearance details

Applicant: Pace Tech Medical Monitors, Inc.
Product code: Code MHX
Advisory panel: Cardiovascular
Date received: 1997-02-05
Decision date: 1998-01-30
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Clearwater, FL, US

Download summary PDF View on FDA.gov ↗

Adverse events under product code MHX

product code MHX

Death: 580
Injury: 2,441
Malfunction: 12,655
Other: 3
Total: 15,679

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.