Electromed SmartVest Airway Clearance System— 510(k) K222496
Substantially EquivalentElectromed, Inc.
FDA 510(k) clearance K222496 for Electromed SmartVest Airway Clearance System, Substantially Equivalent on 2022-11-18. Applicant: Electromed, Inc..
Clearance details
- Applicant
- Electromed, Inc.
- Product code
- Code BYI
- Advisory panel
- Anesthesiology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Special
- Location
- New Prague, MN, 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.