Hemolung Respiratory Assist System
FDA 510(k) clearance DEN210006 · decided 2021-11-13
Clearance details
- K-number
- DEN210006
- Device name
- Hemolung Respiratory Assist System
- Applicant
- Alung Technologies, Inc.
- Decision
- Unknown
- Date received
- 2021-03-04
- Decision date
- 2021-11-13
- Days to decision
- 254 days
- Clearance type
- Direct
- Product code
- QOH
- Device class
- 2
- Regulation number
- 870.4150
- Medical specialty
- Cardiovascular
- Advisory committee
- Cardiovascular
- Location
- Pittsburgh, PA, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.