King of Hearts Express Af Cardiac Event Recorder
FDA 510(k) K111745 · Card Guard Scientific Survival , Ltd.
510(k) numberK111745
Submission
- Device name
- King of Hearts Express Af Cardiac Event Recorder
- Applicant
- Card Guard Scientific Survival , Ltd.
Lakewood, CO, US - Received
- June 21, 2011
- Decision date
- August 1, 2011
- Decision
- Substantially Equivalent (SESE)
- Type
- Special 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- DSH – Recorder, Magnetic Tape, Medical
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 870.2800
- Specialty
- Cardiovascular
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| 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 |
| K081257 | CG-6108 ACT-3L Continuous ECG Monitor & Arrhythmia DetectorDSI · Special | 05/29/2008SE |
| 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 King of Hearts Express Af Cardiac Event Recorder cleared by the FDA?
King of Hearts Express Af Cardiac Event Recorder (K111745) received a 510(k) decision of Substantially Equivalent on August 1, 2011, 41 days after the submission was received.
What is the product code of K111745?
The FDA product code is DSH – Recorder, Magnetic Tape, Medical, a Class II (moderate risk) device regulated under 21 CFR 870.2800.