ESCORT M8 VITAL SIGNS PATIENT MONITOR, MODEL 3810— 510(k) K062144

Substantially Equivalent

Invivo Corporation

FDA 510(k) clearance K062144 for ESCORT M8 VITAL SIGNS PATIENT MONITOR, MODEL 3810, Substantially Equivalent on 2006-10-12. Applicant: Invivo Corporation.

Clearance details

Applicant: Invivo Corporation
Product code: Code MHX
Advisory panel: Cardiovascular
Date received: 2006-07-27
Decision date: 2006-10-12
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Orlando, FL, US

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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.