NEGAVENT PLUS PEGASO COUGH, MODEL: DA-3 PLUS— 510(k) K072292
Substantially EquivalentDima Italia Srl
FDA 510(k) clearance K072292 for NEGAVENT PLUS PEGASO COUGH, MODEL: DA-3 PLUS, Substantially Equivalent on 2008-01-07. Applicant: Dima Italia Srl.
Clearance details
- Applicant
- Dima Italia Srl
- Product code
- Code NHJ
- Advisory panel
- Anesthesiology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Boulder, CO, US
Adverse events under product code NHJ
product code NHJ- Death
- 7
- Total
- 7
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.