The Vest APX System (PVAPX1)— 510(k) K233441
Substantially EquivalentBaxter Healthcare Corportation
FDA 510(k) clearance K233441 for The Vest APX System (PVAPX1), Substantially Equivalent on 2024-03-22. Applicant: Baxter Healthcare Corportation.
Clearance details
- Applicant
- Baxter Healthcare Corportation
- Product code
- Code BYI
- Advisory panel
- Anesthesiology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Deerfield Lake, IL, US
Adverse events under product code BYI
product code BYI- Death
- 3
- Total
- 3
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.