The following data is part of a premarket notification filed by Lung Assist, Inc. with the FDA for Vital Cough.
| Device ID | K120277 |
| 510k Number | K120277 |
| Device Name: | VITAL COUGH |
| Classification | Device, Positive Pressure Breathing, Intermittent |
| Applicant | LUNG ASSIST, INC. 4655 KIRKWOOD COURT Boulder, CO 80301 |
| Contact | Lewis Ward |
| Correspondent | Lewis Ward LUNG ASSIST, INC. 4655 KIRKWOOD COURT Boulder, CO 80301 |
| Product Code | NHJ |
| CFR Regulation Number | 868.5905 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2012-01-30 |
| Decision Date | 2012-09-12 |
| Summary: | summary |
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
![]() VITAL COUGH 85373549 not registered Dead/Abandoned |
Lung Assist, Inc. 2011-07-18 |