MICROLIFE UPPER ARM AUTOMATIC DIGITAL BLOOD PRESSURE MONITOR— 510(k) K131346
Substantially EquivalentMicrolife Intellectual Property GmbH
FDA 510(k) clearance K131346 for MICROLIFE UPPER ARM AUTOMATIC DIGITAL BLOOD PRESSURE MONITOR, Substantially Equivalent on 2013-06-06. Applicant: Microlife Intellectual Property GmbH.
Clearance details
- Applicant
- Microlife Intellectual Property GmbH
- Product code
- Code DXN
- Advisory panel
- Cardiovascular
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Special
- Location
- Great Neck, NY, US
Adverse events under product code DXN
product code DXN- Death
- 3
- Injury
- 169
- Malfunction
- 1,019
- Other
- 2
- Total
- 1,193
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.