MEDICALGORITHMICS REAL-TIME ECG MONITOR AND ARRHYTHMIA DETECTOR, MODEL POCKETECG— 510(k) K090037
Substantially EquivalentMedicalgorithmics SP Z.O.O.
FDA 510(k) clearance K090037 for MEDICALGORITHMICS REAL-TIME ECG MONITOR AND ARRHYTHMIA DETECTOR, MODEL POCKETECG, Substantially Equivalent on 2009-05-22. Applicant: Medicalgorithmics SP Z.O.O..
Clearance details
- Applicant
- Medicalgorithmics SP Z.O.O.
- Product code
- Code DSI
- Advisory panel
- Cardiovascular
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Abbreviated
- Location
- New York, NY, US
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.