Hemolung Respiratory Assist System— 510(k) DEN210006
UnknownAlung Technologies, Inc.
FDA 510(k) clearance DEN210006 for Hemolung Respiratory Assist System, Unknown on 2021-11-13. Applicant: Alung Technologies, Inc.. Device class: 2.
Clearance details
- Applicant
- Alung Technologies, Inc.
- Product code
- Code QOH
- Device class
- Class 2
- Regulation
- 21 CFR 870.4150
- Advisory panel
- Cardiovascular
- Date received
- Decision date
- Decision
- Unknown
- Clearance type
- Direct
- Location
- Pittsburgh, PA, US
Adverse events under product code QOH
product code QOH- Death
- 5
- Total
- 5
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.