HORIZON CARDIOLOGY ECG MANAGEMENT— 510(k) K113515
Substantially EquivalentMckesson Israel , Ltd.
FDA 510(k) clearance K113515 for HORIZON CARDIOLOGY ECG MANAGEMENT, Substantially Equivalent on 2012-03-16. Applicant: Mckesson Israel , Ltd.. Device class: 2.
Clearance details
- Applicant
- Mckesson Israel , Ltd.
- Product code
- Code DQK
- Device class
- Class 2
- Regulation
- 21 CFR 870.1425
- Advisory panel
- Cardiovascular
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Tel Aviv, IL
Recent devices under product code DQK
view allMore clearances from Mckesson Israel , Ltd.
view allAdverse events under product code DQK
product code DQK- Death
- 10
- Injury
- 225
- Malfunction
- 2,123
- Other
- 2
- Total
- 2,360
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 →
Recalls naming K113515
K-number listed on FDA's recall record- Z-1682-2020 — McKesson Cardiology ECG Management, Change Healthcare Cardiology ECG Management
- Z-0910-2015 — McKesson Cardiology ECG Management It is a software application designed to import, display, store, analyze, distribute and manage information related to ECG procedures of adult and pediatric patients from external ECG devices.
Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K113515.
Data sourced from openFDA. This site is unofficial and independent of the FDA.