CG-6108 ACT-3L CONTINUOUS ECG MONITOR & ARRHYTHMIA DETECTOR
FDA 510(k) clearance K081257 · decided 2008-05-29
Clearance details
- K-number
- K081257
- Device name
- CG-6108 ACT-3L CONTINUOUS ECG MONITOR & ARRHYTHMIA DETECTOR
- Applicant
- Card Guard Scientific Survival , Ltd.
- Decision
- Substantially Equivalent
- Date received
- 2008-05-02
- Decision date
- 2008-05-29
- Days to decision
- 27 days
- Clearance type
- Special
- Product code
- DSI
- Device class
- 2
- Regulation number
- 870.1025
- Medical specialty
- Cardiovascular
- Advisory committee
- Cardiovascular
- Location
- Rehovot, IL
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
| Record | Firm | Date |
|---|---|---|
| LifeStar ACT III Platinum Sensor Ambulatory Cardiac Telemetry; an automatically activated recall (Z-0207-2012) | Lifewatch Services Inc | 2011-11-17 |
| ACT Cellular Phone Monitor; a component of the ACT Ambulatory Cardiac Telemetry; an automa recall (Z-0208-2012) | Lifewatch Services Inc | 2011-11-17 |