K062754
Substantially EquivalentGAS MODULE SE, MODEL 0998-00-0481-02
- Applicant
- Datascope Corp.
- Product code
- BZK
- Advisory panel
- Anesthesiology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Mahwh, NJ, US
Adverse events under product code BZK
product code BZK- Death
- 2
- Total
- 2
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.