CARDIOMEM— 510(k) K122272
Substantially EquivalentGetemed Medizin- Und Informationstechnik AG
FDA 510(k) clearance K122272 for CARDIOMEM, Substantially Equivalent on 2013-03-28. Applicant: Getemed Medizin- Und Informationstechnik AG.
Clearance details
- Applicant
- Getemed Medizin- Und Informationstechnik AG
- Product code
- Code MWJ
- Advisory panel
- Cardiovascular
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Special
- Location
- Great Neck, NY, US
Adverse events under product code MWJ
product code MWJ- Other
- 1
- Total
- 1
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.