COROMETRICS 5566AAX NONINVASIVE BLOOD PRESSURE MOD— 510(k) K911310
Substantially EquivalentGe Medical Systems Information Technologies
FDA 510(k) clearance K911310 for COROMETRICS 5566AAX NONINVASIVE BLOOD PRESSURE MOD, Substantially Equivalent on 1991-06-10. Applicant: Ge Medical Systems Information Technologies.
Clearance details
- Applicant
- Ge Medical Systems Information Technologies
- Product code
- Code DXN
- Advisory panel
- Cardiovascular
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Wallingford, CT, 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.