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

Name: FDA 510(k) clearance K973474
Creator: U.S. Food and Drug Administration
Published: 1998-03-13

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. Device class: 2.

Clearance details

Applicant: Witt Biomedical Corporation
Product code: Code MHX
Device class: Class 2
Regulation: 21 CFR 870.1025
Advisory panel: Cardiovascular
Date received: 1997-09-12
Decision date: 1998-03-13
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Melbourne, FL, US

Download summary PDF View on FDA.gov ↗

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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.