FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
CARDIONET AMBULATORY ECG MONITOR WITH ARRHYTHMIA DETECTION, MODEL CN1001
K Number: K012241
·
Decision Feb 1, 2002
Classifications
1
FEI Numbers
121
Registration Numbers
121
Same Product Code
395
Applicant Total
6
Review Days
199
Basic Information
- Device Name
- CARDIONET AMBULATORY ECG MONITOR WITH ARRHYTHMIA DETECTION, MODEL CN1001
- K Number
- K012241
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 870.1025
- Medical Specialty
- Cardiovascular
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- CARDIONET, INC
- Date Received
- July 17, 2001
- Decision Date
- February 1, 2002
- Product Code
- DSI
- Advisory Committee
- Cardiovascular
- Review Advisory Committee
- CV
- Third Party
- N
Classifications
This FDA 510(k) entry is associated with 1 FDA classification via its product code.
| Product Code | Device Name | Device Class | Medical Specialty |
|---|---|---|---|
| DSI | Detector And Alarm, Arrhythmia | FDA class 2 | Cardiovascular |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (DSI), ordered by most recent decision date.
Zio AT® device (A100A1001)
FDA 510(k)
FDA Class 2
·Cardiovascular
MoMe® ARC Wireless Ambulatory ECG Monitoring and Detection System
FDA 510(k)
FDA Class 2
·Cardiovascular
SmartCardia 7L Platform
FDA 510(k)
FDA Class 2
·Cardiovascular
Unified Arrhythmia Diagnostic System PocketECG IV
FDA 510(k)
FDA Class 2
·Cardiovascular
BodyGuardian Remote Monitoring System
FDA 510(k)
FDA Class 2
·Cardiovascular
Patient Assistant Model PA97000
FDA 510(k)
FDA Class 2
·Cardiovascular
Other Clearances by CARDIONET, INC
| K Number | Device Name | ||
|---|---|---|---|
| K093288 | CARDIONET AMBULATORY ECG MONITOR WITH ARRHYTHMIA DETECTION | Apr 8, 2010 | Substantially Equivalent |
| K072558 | CARDIONET AMBULATORY ECG MONITOR WITH ARRHYTHMIA DETECTION, MODEL CN1005 | Dec 5, 2007 | Substantially Equivalent |
| K063222 | CARDIONET AMBULATORY ECG MONITOR WITH ARRHYTHMIA DETECTION, MODEL CN1004 | Nov 14, 2006 | Substantially Equivalent |
| K053263 | CARDIONET AMBULATORY ECG MONITOR WITH ARRHYTHMIA DETECTION, MODEL CN1003 | Apr 25, 2006 | Substantially Equivalent |
| K052240 | CARDIONET AMBULATORY ECG MONITOR WITH ARRHYTHMIA DETECTION, MODEL 1002 | Oct 19, 2005 | Substantially Equivalent |