510(k) K925510 ยท DSI Detector And Alarm, Arrhythmia
MODEL 90478 & 90479 TELEMETRY REC. MODULE&HOUSING
| Applicant | Spacelabs Medical, Inc., Hamden CT, US |
| Decision | Substantially Equivalent, Oct 27, 1994 |
| Received | Oct 30, 1992 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K925510
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Sep 18, 2008 | Spacelabs Healthcare, Incorporated Ultraview Digital Telemetry Transmitter, Model 90478
The Spacelabs Medical Digital Telemetry system provides continuous electrocardiographic (ECG) monitoring to detect ST segment changes, abnormal car Terminated |
DSI | None listed |
| Jul 6, 2006 | Spacelabs Medical Incorporated Spacelabs Medical 1400 MHz Telemetry System,. Model 91341-09. Telemetry System consists of Model 91341-09 transmitter, 90478-1CST receiver and 90478-1CSV receiver. Terminated |
DSI | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.