# K121208: Obix Perinatal Data System 7.0

- Pathway: 510(k) (Traditional)
- Applicant: Clinical Computer Systems, Inc.
- Decided: Jun 14, 2012 after 55 days
- Product code: HGM (System, Monitoring, Perinatal)
- Device class: 2
- Regulation: 21 CFR 884.2740
- 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
For obstetrical patients, the OBIX Perinatal Data System 7.0 provides health care professionals a method to display and archive electronic fetal monitor data and manage demographic information and documentation. The intended use of the OBDC system is displaying and recording fetal and maternal physiological data obtained from electronic fetal monitors. The OBIX system also has these capabilities: * Monitors fetal and maternal physiological data obtained from standard electronic fetal monitors and accompanying accessories and captures it on permanent storage media. * Displays the monitored data for one or more patients in the patient rooms and at other locations as required by the hospital. * Supports patient management activities, including note entry onto the electronic fetal monitor tracings and into the medical record. * Provides tools that assist clinicians in evaluating fetal heart rate patterns. * Generates flowsheets and graphs based on the notes recorded for the patient. * The optional Registration Interface registers patients in the OBIX system directly from the hospital's admissions system. Patients can also be registered in the OBD( system manually, whqn necessary. * Displays the Status Board (chalkboard), which shows patient roonms and key data elements in real-time format. The Status Board is typically displayed at one or more central locations, usually at the central nurses' station. * Provides optional remote access to patient monitoring and management activities through off-site workstations connected by a virtual private network (VPN) connection or a secure hospital Web page.

Source page: https://510kreport.com/device/K121208
Methodology: https://510kreport.com/methodology