510(k) K101639 ยท DSI Detector And Alarm, Arrhythmia
CG-6108 ACT-IL CONTINUOUS ECG MONITOR AND ARRYTHMIA DETECTOR
| Applicant | Card Guard Scientific Survival , Ltd., Lakewood CO, US |
| Decision | Substantially Equivalent, Jun 25, 2010 |
| Received | Jun 10, 2010 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K101639
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Nov 17, 2011 | Lifewatch Services Inc LifeStar ACT I Sensor Ambulatory Cardiac Telemetry; an automatically activated system with a single channel EKG, office hookup and auto send/auto detect that requires no patient intervention to either Terminated |
DXH | None listed |
| Nov 17, 2011 | Lifewatch Services Inc ACT Cellular Phone Monitor; a component of the ACT Ambulatory Cardiac Telemetry; an automatically activated system with a high performance EKG, office hookup and auto send/auto detect that requires no Terminated |
DXH | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.