AIR PLUS NEBULIZER— 510(k) K902520
Substantially EquivalentDiamond Medical Equipment, Inc.
FDA 510(k) clearance K902520 for AIR PLUS NEBULIZER, Substantially Equivalent on 1991-03-04. Applicant: Diamond Medical Equipment, Inc..
Clearance details
- Applicant
- Diamond Medical Equipment, Inc.
- Product code
- Code BTI
- Advisory panel
- Anesthesiology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Jamaica, NY, US
Adverse events under product code BTI
product code BTI- Death
- 25
- Malfunction
- 1,168
- 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.