Cardionet Ambulatory ECG Monitor with Arrhythmia Detection, Model 1002
FDA 510(k) K052240 · Cardionet, Inc.
Submission
- Device name
- Cardionet Ambulatory ECG Monitor with Arrhythmia Detection, Model 1002
- Applicant
- Cardionet, Inc.
San Diego, CA, US - Received
- August 17, 2005
- Decision date
- October 19, 2005
- Decision
- Substantially Equivalent (SESE)
- Type
- Abbreviated 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- QYX – Outpatient Cardiac Telemetry
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 870.1025
- Specialty
- Cardiovascular
Devices are intended to continuously record and analyze electrocardiograms for automatic detection and recording of cardiac electrical activity in an outpatient setting. Detected, notifiable events are transmitted to the prescribing clinician during the monitoring period by a 24/7 attended analysis center after review by a qualified individual. Devices may allow remote access and display of…
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More from Infobionic, Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K093288 | Cardionet Ambulatory ECG Monitor with Arrhythmia DetectionQYX · Abbreviated | 04/08/2010SE |
| K072558 | Cardionet Ambulatory ECG Monitor with Arrhythmia Detection, Model CN1005QYX · Abbreviated | 12/05/2007SE |
| K063222 | Cardionet Ambulatory ECG Monitor with Arrhythmia Detection, Model CN1004QYX · Special | 11/14/2006SE |
| K053263 | Cardionet Ambulatory ECG Monitor with Arrhythmia Detection, Model CN1003DSI · Abbreviated | 04/25/2006SE |
| K012241 | Cardionet Ambulatory ECG Monitor with Arrhythmia Detection, Model CN1001DSI · Traditional | 02/01/2002SE |
| K003707 | Cardionet Ambulatory ECG Monitor, Model CN1000AMWJ · Traditional | 05/16/2001SE |
Questions and answers
When was Cardionet Ambulatory ECG Monitor with Arrhythmia Detection, Model 1002 cleared by the FDA?
Cardionet Ambulatory ECG Monitor with Arrhythmia Detection, Model 1002 (K052240) received a 510(k) decision of Substantially Equivalent on October 19, 2005, 63 days after the submission was received.
What is the product code of K052240?
The FDA product code is QYX – Outpatient Cardiac Telemetry, a Class II (moderate risk) device regulated under 21 CFR 870.1025.