510(k) DEN210006
- Device
- Hemolung Respiratory Assist System
- Applicant
- Alung Technologies, Inc.
- 510(k) number
- DEN210006
- Product code
- QOH
- Decision
- Unknown (DENG)
- Decision date
- 2021-11-13
- Date received
- 2021-03-04
- Regulation
- 870.4150
- Classification name
- Extracorporeal System For Carbon Dioxide Removal
- Medical specialty
- Cardiovascular
- Review panel
- Cardiovascular
- Device class
- 2
- Clearance type
- Direct
- Third party reviewed
- N
Applicant Contact#
- Contact
- Joe Argyros
- Address
- 2500 Jane St. Suite #1 Pittsburgh PA US 15203 15203
Source Documents#
510(k) summary PDF not indicated by FDA