NAVIGATOR ANESTHESIA DELIVERY SYSTEM, MODEL 0998-00-3024-01— 510(k) K080175
Substantially EquivalentDatascope Corp., Patient Monitoring Division
FDA 510(k) clearance K080175 for NAVIGATOR ANESTHESIA DELIVERY SYSTEM, MODEL 0998-00-3024-01, Substantially Equivalent on 2008-06-09. Applicant: Datascope Corp., Patient Monitoring Division.
Clearance details
- Applicant
- Datascope Corp., Patient Monitoring Division
- Product code
- Code BSZ
- Advisory panel
- Anesthesiology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Abbreviated
- Location
- Mahwh, NJ, US
Adverse events under product code BSZ
product code BSZ- Death
- 23
- Injury
- 298
- Malfunction
- 32,987
- Total
- 33,308
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.