MODIFICATION TO BERNOULLI VENTILATOR MANAGEMENT SYSTEM SOFTWARE— 510(k) K051283
Substantially EquivalentCardiopulmonary Corp.
FDA 510(k) clearance K051283 for MODIFICATION TO BERNOULLI VENTILATOR MANAGEMENT SYSTEM SOFTWARE, Substantially Equivalent on 2005-06-23. Applicant: Cardiopulmonary Corp..
Clearance details
- Applicant
- Cardiopulmonary Corp.
- Product code
- Code MSX
- Advisory panel
- Cardiovascular
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Special
- Location
- Milford, CT, US
Adverse events under product code MSX
product code MSX- Death
- 59
- Total
- 59
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.