CARDIONET AMBULATORY ECG MONITOR WITH ARRHYTHMIA DETECTION— 510(k) K093288
Substantially EquivalentCardionet, Inc.
FDA 510(k) clearance K093288 for CARDIONET AMBULATORY ECG MONITOR WITH ARRHYTHMIA DETECTION, Substantially Equivalent on 2010-04-08. 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
- Abbreviated
- Location
- San Diego, CA, US
Recent devices under product code QYX
view allMore clearances from Cardionet, Inc.
view all- K072558 — CARDIONET AMBULATORY ECG MONITOR WITH ARRHYTHMIA DETECTION, MODEL CN1005
- K063222 — CARDIONET AMBULATORY ECG MONITOR WITH ARRHYTHMIA DETECTION, MODEL CN1004
- 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.