KING OF HEARTS EXPRESS AF CARDIAC EVENT RECORDER— 510(k) K111745
Substantially EquivalentCard Guard Scientific Survival , Ltd.
FDA 510(k) clearance K111745 for KING OF HEARTS EXPRESS AF CARDIAC EVENT RECORDER, Substantially Equivalent on 2011-08-01. Applicant: Card Guard Scientific Survival , Ltd.. Device class: 2.
Clearance details
- Applicant
- Card Guard Scientific Survival , Ltd.
- Product code
- Code DSH
- Device class
- Class 2
- Regulation
- 21 CFR 870.2800
- Advisory panel
- Cardiovascular
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Special
- Location
- Lakewood, CO, US
Recent devices under product code DSH
view allMore clearances from Card Guard Scientific Survival , Ltd.
view all- K110499 — CG-5108 ACT-3L CONTINUOUS ECG MONITOR AND ARRHYTHMIA DETECTOR
- K101703 — MODIFICATION TO: CG-6108 ACT-3L CONTINUOUS ECG MONITOR AND ARRHYTHMIA DETECTOR, MODEL FG-00084
- K101639 — CG-6108 ACT-IL CONTINUOUS ECG MONITOR AND ARRYTHMIA DETECTOR
- K083174 — HEALTHEPOD
- K082521 — EASY2CHECK BLOOD GLUCOSE AND BLOOD PRESSURE MONITORING SYSTEM
Adverse events under product code DSH
product code DSH- Death
- 3
- Injury
- 652
- Total
- 655
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.