1481 T Digital Telemetry Systems, Enhanced
by Siemens Medical Solutions USA, Inc.
510(k) K945384
Active
Valid until
No expiry
FDA recalls
None found
Documents
Trust
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK945384 | Date10 May 1995 | StatusActive |
Official records
- FDA 510(k) database K945384
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
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
Overview
AI-generated summary, 20 Sep 2026
The 1481 T Digital Telemetry Systems, Enhanced is a Detector and Alarm for Arrhythmia (product code DSI), classified as a Class II medical device under 21 CFR 870.1025. This system is designed to monitor cardiac electrical activity, detect arrhythmias, and trigger alarms to alert clinical staff of abnormal heart rhythms, supporting real-time patient assessment in cardiovascular settings.
This device is intended for use in clinical environments where continuous cardiac monitoring is required, such as intensive care units, cardiac catheterization labs, or emergency departments. Supplied as a reusable system, it adheres to regulatory standards established by the FDA under a 510(k) clearance (K945384) granted in 1995. The system is not specified as MRI-safe or single-use, and its operational specifications—including size, storage, or sterilization—are not detailed in the provided data.