CARDIONET AMBULATORY ECG MONITOR WITH ARRHYTHMIA DETECTION, MODEL CN1003— 510(k) K053263
Substantially EquivalentCardionet, Inc.
FDA 510(k) clearance K053263 for CARDIONET AMBULATORY ECG MONITOR WITH ARRHYTHMIA DETECTION, MODEL CN1003, Substantially Equivalent on 2006-04-25. Applicant: Cardionet, Inc.. Device class: 2.
Clearance details
- Applicant
- Cardionet, Inc.
- Product code
- Code DSI
- Device class
- Class 2
- Regulation
- 21 CFR 870.1025
- Advisory panel
- Cardiovascular
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Abbreviated
- Location
- San Diego, CA, US
Recent devices under product code DSI
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
- K063222 — CARDIONET AMBULATORY ECG MONITOR WITH ARRHYTHMIA DETECTION, MODEL CN1004
- 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 DSI
product code DSI- Death
- 170
- Injury
- 729
- Malfunction
- 10,680
- Total
- 11,579
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.