CG-6108 ACT-3L Continuous ECG Monitor & Arrhythmia Detector
FDA 510(k) K081257 · Card Guard Scientific Survival , Ltd.
510(k) numberK081257
Submission
- Device name
- CG-6108 ACT-3L Continuous ECG Monitor & Arrhythmia Detector
- Applicant
- Card Guard Scientific Survival , Ltd.
Rehovot, IL - Received
- May 2, 2008
- Decision date
- May 29, 2008
- Decision
- Substantially Equivalent (SESE)
- Type
- Special 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- DSI – Detector And Alarm, Arrhythmia
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 870.1025
- Specialty
- Cardiovascular
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| K250356 | MoMe ARC® Wireless Ambulatory ECG Monitoring and Detection System (32000)DSI · Traditional | Infobionic, Inc. | 07/29/2025SE |
| K240177 | Zio AT® device (A100A1001)DSI · Traditional | iRhythm Technologies, Inc. | 10/30/2024SE |
| K230265 | MoMe® ARC Wireless Ambulatory ECG Monitoring and Detection SystemDSI · Abbreviated | Infobionic, Inc. | 10/06/2023SE |
| K231276 | SmartCardia 7L PlatformDSI · Traditional | Smartcardia SA | 08/30/2023SE |
| K193104 | Unified Arrhythmia Diagnostic System PocketECG IVDSI · Special | Medicalgorithmics S.A. | 04/09/2020SE |
| K192732 | BodyGuardian Remote Monitoring SystemDSI · Traditional | Preventice Technologies, Inc. | 03/26/2020SE |
| K190574 | Patient Assistant Model PA97000DSI · Traditional | Medtronic, Inc. | 09/24/2019SE |
| K182532 | Liba3 SystemDSI · Traditional | National Cardiac, Inc. | 05/15/2019SE |
| K181658 | MobileECG 2 BTDSI · Traditional | Memtec Corporation | 03/26/2019SE |
More from Memtec Corporation
| 510(k) | Device | Decision |
|---|---|---|
| K111745 | King of Hearts Express Af Cardiac Event RecorderDSH · Special | 08/01/2011SE |
| K110499 | CG-5108 ACT-3L Continuous ECG Monitor and Arrhythmia DetectorDSI · Special | 04/06/2011SE |
| K101703 | Modification to: CG-6108 ACT-3L Continuous ECG Monitor and Arrhythmia Detector, Model…DSI · Special | 07/13/2010SE |
| K101639 | CG-6108 Act-Il Continuous ECG Monitor and Arrythmia DetectorDSI · Special | 06/25/2010SE |
| K083174 | HealthepodDXH · Traditional | 12/17/2009SE |
| K082521 | EASY2CHECK Blood Glucose and Blood Pressure Monitoring SystemNBW · Traditional | 01/16/2009SE |
| K071995 | CG-6108 Continuous ECG Monitor and Arrhythmia DetectorDSI · Traditional | 12/18/2007SE |
| K061428 | PMP4 ApplicationMSX · Traditional | 10/16/2006SE |
| K061528 | Selfcheck GlucoCGA · Traditional | 09/22/2006SE |
| K060911 | CG-6108 Arrhythmia ECG Event RecorderDXH · Special | 08/22/2006SE |
Questions and answers
When was CG-6108 ACT-3L Continuous ECG Monitor & Arrhythmia Detector cleared by the FDA?
CG-6108 ACT-3L Continuous ECG Monitor & Arrhythmia Detector (K081257) received a 510(k) decision of Substantially Equivalent on May 29, 2008, 27 days after the submission was received.
What is the product code of K081257?
The FDA product code is DSI – Detector And Alarm, Arrhythmia, a Class II (moderate risk) device regulated under 21 CFR 870.1025.