ACCUTORR V MONITOR, MODEL 0998-00-2000— 510(k) K091068
Substantially EquivalentDatascope Corp., Patient Monitoring Division
FDA 510(k) clearance K091068 for ACCUTORR V MONITOR, MODEL 0998-00-2000, Substantially Equivalent on 2009-05-08. Applicant: Datascope Corp., Patient Monitoring Division.
Clearance details
- Applicant
- Datascope Corp., Patient Monitoring Division
- Product code
- Code DXN
- Advisory panel
- Cardiovascular
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Special
- Location
- Mahwh, NJ, 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.