Ultipor U55/U55N Breathing Circuit Filter and Heat and Moisture Exchanger— 510(k) K211286
Substantially EquivalentPall Corporation
FDA 510(k) clearance K211286 for Ultipor U55/U55N Breathing Circuit Filter and Heat and Moisture Exchanger, Substantially Equivalent on 2021-11-16. Applicant: Pall Corporation.
Clearance details
- Applicant
- Pall Corporation
- Product code
- Code CAH
- Advisory panel
- Anesthesiology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Port Washington, NY, US
Adverse events under product code CAH
product code CAH- Death
- 7
- 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.