510(k) K092947 ยท DSI Detector And Alarm, Arrhythmia
TELESENTRY, MODEL TS01
| Applicant | Scottcare Corporation, Cleveland OH, US |
| Decision | Substantially Equivalent, Feb 26, 2010 |
| Received | Sep 24, 2009 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K092947
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Feb 25, 2016 | Scottcare Corporation TeleSentry Battery, 3.7 Li-Ion Polymer Battery, CAUTION Do not expose to high temperature. Do not disassemble. Dispose of properly. Use specified charger only. 60pC/140pF The ScottCare Corporation.
Terminated |
DSI | None listed |
| Apr 13, 2012 | Scottcare Corporation TeleSentry, Multi-parameter Ambulatory Telemetry, Model #TS01. Dist. By: ScottCare Corporation, Cleveland, OH.
The TeleSentry device is intended for diagnostic evaluation of patients who experience t Terminated |
DSI | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.