MAC-LAB HEMODYNAMIC RECORDING SYSTEM; CARDIOLAB ELECTROPHYSIOLOGY RECORDING SYSTEM; COMBOLAB HEMODYNAMIC AND ELECTROPHYS— 510(k) K130626
Substantially EquivalentGe Medical Systems Information Technologies, Inc.
FDA 510(k) clearance K130626 for MAC-LAB HEMODYNAMIC RECORDING SYSTEM; CARDIOLAB ELECTROPHYSIOLOGY RECORDING SYSTEM; COMBOLAB HEMODYNAMIC AND ELECTROPHYS, Substantially Equivalent on 2013-05-01. Applicant: Ge Medical Systems Information Technologies, Inc..
Clearance details
- Applicant
- Ge Medical Systems Information Technologies, Inc.
- Product code
- Code DQK
- Advisory panel
- Cardiovascular
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Special
- Location
- Milwaukee, WI, US
Adverse events under product code DQK
product code DQK- Death
- 10
- Injury
- 225
- Malfunction
- 2,123
- Other
- 2
- Total
- 2,360
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.