Ignite Creation Date:
2024-05-06 @ 1:12 PM
Last Modification Date:
2024-10-26 @ 1:11 PM
Study NCT ID:
NCT03969797
Status:
COMPLETED
Last Update Posted:
2019-05-31
First Post:
2019-05-27
Brief Title:
AED Log Analysis of 19 Cases in Out-of-hospital Environment
Sponsor:
RadianQbio
Organization:
RadianQbio
Study Overview
Official Title:
Quality Feedback of 19 Cases by AED Operation in Out-of-hospital Environment a Prospective Randomized Log Analysis
Status:
COMPLETED
Status Verified Date:
2019-05
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The study performed to demonstrate a reasonable assurance of safety and effectiveness of the Heart Guardian HR-501 when used in an out-of-hospital environment
Detailed Description:
The defibrillation study was conducted by analyzing the logs of Heart Guardian HR-501 with Radian ECG Viewer The product analysis was studied whether the device was operated normally in ECG analysis and electric shocks
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None