Oxford VDT-40 Display Terminal
by Oxford Medilog, Inc. 510(k)
Active
510(k) K852207
Overview
The Oxford VDT-40 Display Terminal is a Detector and Alarm Device for Arrhythmia, classified under FDA product code DSI (Diagnostic Subsystems). This device is designed to visually display and monitor cardiac arrhythmias, providing real-time arrhythmia detection and alarm signaling for clinical assessment. It serves as an integral component in cardiovascular monitoring systems, aiding healthcare professionals in identifying and responding to abnormal heart rhythms.
The Oxford VDT-40 is intended for use in clinical settings, such as hospitals or cardiac care units, where continuous cardiac monitoring is required. Supplied as a reusable device, it is regulated under FDA 510(k) clearance (K852207) and falls under Class II medical devices. No specific sterility or MRI safety information is provided in the data. The device was authorized for use in the United States following a traditional 510(k) review process by the FDA’s Cardiovascular (CV) Advisory Committee in 1985. No additional storage or size specifications are detailed in the provided data.
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK852207 | Date11 Jun 1985 | StatusActive |
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not known
- Not covered
United States — FDA 510(k) Active
Recalls
No FDA recalls on record, checked 22 Oct 2026.
Specification
- 510(k) Number
- FDA Product Code
- DSI
- Device Class
- Class II
- Regulation
- 21 CFR Part 870.1025
- Advisory Committee
- Cardiovascular
- FDA Decision
- SESE Substantially Equivalent