The following data is part of a premarket notification filed by Lung Assist, Inc. with the FDA for Vital Cough.
Device ID | K132988 |
510k Number | K132988 |
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 | 2013-09-24 |
Decision Date | 2014-03-28 |
Summary: | summary |
Mark Image Registration | Serial | Company Trademark Application Date |
---|---|
VITAL COUGH 85373549 not registered Dead/Abandoned |
Lung Assist, Inc. 2011-07-18 |