ORAL/ENTERAL SYRINGES— 510(k) K100099
Substantially EquivalentPhilips Children'S Medical Ventures
FDA 510(k) clearance K100099 for ORAL/ENTERAL SYRINGES, Substantially Equivalent on 2010-06-14. Applicant: Philips Children'S Medical Ventures.
Clearance details
- Applicant
- Philips Children'S Medical Ventures
- Product code
- Code FPD
- Advisory panel
- Gastroenterology, Urology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Monroeville, PA, US
Adverse events under product code FPD
product code FPD- Death
- 6
- Other
- 1
- Total
- 7
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.