WITT BIOMEDICAL CENTRAL STATION MONITORING SYSTEM AND WITT BIOMEDICAL ADVANCED PATIENT CARE MONITORING UNITS— 510(k) K973474

Substantially Equivalent

Witt Biomedical Corporation

FDA 510(k) clearance K973474 for WITT BIOMEDICAL CENTRAL STATION MONITORING SYSTEM AND WITT BIOMEDICAL ADVANCED PATIENT CARE MONITORING UNITS, Substantially Equivalent on 1998-03-13. Applicant: Witt Biomedical Corporation.

Clearance details

Applicant: Witt Biomedical Corporation
Product code: Code MHX
Advisory panel: Cardiovascular
Date received: 1997-09-12
Decision date: 1998-03-13
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Melbourne, 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.