INFANT PERCUSSOR #5534— 510(k) K812803
Substantially EquivalentHudson Oxygen Therapy Sales Co.
FDA 510(k) clearance K812803 for INFANT PERCUSSOR #5534, Substantially Equivalent on 1981-12-03. Applicant: Hudson Oxygen Therapy Sales Co..
Clearance details
- Applicant
- Hudson Oxygen Therapy Sales Co.
- Product code
- Code BYI
- Advisory panel
- Anesthesiology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Walker, MI, 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.