510(k) K110499 ยท DSI Detector And Alarm, Arrhythmia
CG-5108 ACT-3L CONTINUOUS ECG MONITOR AND ARRHYTHMIA DETECTOR
| Applicant | Card Guard Scientific Survival , Ltd., Lakewood CO, US |
| Decision | Substantially Equivalent, Apr 6, 2011 |
| Received | Feb 22, 2011 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K110499
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Nov 17, 2011 | Lifewatch Services Inc LifeStar ACT III Platinum Sensor Ambulatory Cardiac Telemetry; an automatically activated system with a high performance triple channel EKG, office hookup and auto send/auto detect that requires no pa 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.