PRONEB ULTRA MODEL NUMBER 85B0100— 510(k) K002862
Substantially EquivalentPari Holding Co.
FDA 510(k) clearance K002862 for PRONEB ULTRA MODEL NUMBER 85B0100, Substantially Equivalent on 2001-03-13. Applicant: Pari Holding Co..
Clearance details
- Applicant
- Pari Holding Co.
- Product code
- Code BTI
- Advisory panel
- Anesthesiology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Midlothian, VA, 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.