AGILENT COMPONENT MONITORING SYSTEM, AGILENT CARDIAC OUTPUT MODULE, AGILENT INVASIVE PRESSURE MODULE, MODEL M1175A/76A— 510(k) K002758
Substantially EquivalentAgilent Technologies Deutschland GmbH
FDA 510(k) clearance K002758 for AGILENT COMPONENT MONITORING SYSTEM, AGILENT CARDIAC OUTPUT MODULE, AGILENT INVASIVE PRESSURE MODULE, MODEL M1175A/76A, Substantially Equivalent on 2001-02-22. Applicant: Agilent Technologies Deutschland GmbH.
Clearance details
- Applicant
- Agilent Technologies Deutschland GmbH
- Product code
- Code DSI
- Advisory panel
- Cardiovascular
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Boeblingen,, DE
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.