AIR STAR— 510(k) K920954
Substantially EquivalentInfrasonics Corp.
FDA 510(k) clearance K920954 for AIR STAR, Substantially Equivalent on 1992-08-03. Applicant: Infrasonics Corp..
Clearance details
- Applicant
- Infrasonics Corp.
- Product code
- Code BTI
- Advisory panel
- Anesthesiology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- San Diego, CA, 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.