# K973474: Witt Biomedical Central Station Monitoring System and Witt Biomedical Advanced Patient Care Monitoring Units

- Pathway: 510(k) (Traditional)
- Applicant: Witt Biomedical Corporation
- Decided: Mar 13, 1998 after 182 days
- Product code: MHX (Monitor, Physiological, Patient(With Arrhythmia Detection Or Alarms))
- Device class: 2
- Regulation: 21 CFR 870.1025
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
No later device cites it as a predicate yet.
0 of 1 device in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA’s file for it is a 510(k) statement, which names no predicate.

## Indications for use
The Witt Biomedical Central Station Monitor and Advanced Patient Care Monitoring Units are designed to monitor, store and display patient data. User adjustable alarms (both visual and audible), alert the operator to anomalous occurrences and facilitate timely responses. The Wit Biomedical Central Station Monitor and/or Advanced Patient Care Monitoring unit are intended for use in hospital environments including coronary care, post anesthesia recovery, operating room, critical care, surgical intensive care, respiratory intensive care, medical intensive care, pediatric intensive care, neonatal intensive care and patient holding areas of health care facilities. The Witt Biomedical Central Station Monitor and Advanced Patient Care Monitoring Unit offers a thorough list of monitoring parameters which use proven algorithms of the Witt Biomedical Series IV. Patient information is displayed in a logical, easily understood format that requires minimal training. Operation parallels the Witt Series IV, affording familiarity to the users of any Witt Biomedical system. The Witt Biomedical Central Station Monitor and Advanced Patient Care Monitoring Units are intended for use by physicians, physician assistants, registered nurses, or other qualified hospital personnel with training on the operation of this equipment.

Source page: https://510kreport.com/device/K973474
Methodology: https://510kreport.com/methodology