CARDIONET AMBULATORY ECG MONITOR WITH ARRHYTHMIA DETECTION, MODEL CN1004— 510(k) K063222
Substantially EquivalentCardionet, Inc.
FDA 510(k) clearance K063222 for CARDIONET AMBULATORY ECG MONITOR WITH ARRHYTHMIA DETECTION, MODEL CN1004, Substantially Equivalent on 2006-11-14. Applicant: Cardionet, Inc.. Device class: 2.
Clearance details
- Applicant
- Cardionet, Inc.
- Product code
- Code QYX
- Device class
- Class 2
- Regulation
- 21 CFR 870.1025
- Advisory panel
- Cardiovascular
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Special
- Location
- San Diego, CA, US
Recent devices under product code QYX
view allMore clearances from Cardionet, Inc.
view all- K093288 — CARDIONET AMBULATORY ECG MONITOR WITH ARRHYTHMIA DETECTION
- K072558 — CARDIONET AMBULATORY ECG MONITOR WITH ARRHYTHMIA DETECTION, MODEL CN1005
- K053263 — CARDIONET AMBULATORY ECG MONITOR WITH ARRHYTHMIA DETECTION, MODEL CN1003
- K052240 — CARDIONET AMBULATORY ECG MONITOR WITH ARRHYTHMIA DETECTION, MODEL 1002
- K012241 — CARDIONET AMBULATORY ECG MONITOR WITH ARRHYTHMIA DETECTION, MODEL CN1001
Adverse events under product code QYX
product code QYX- Death
- 13
- Malfunction
- 526
- Total
- 539
Source: openFDA MAUDE database, through . Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →
Data sourced from openFDA. This site is unofficial and independent of the FDA.