Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links
  • Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

510(k) Premarket Notification
  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 


New Search Back To Search Results
Device Classification Name Device, Positive Pressure Breathing, Intermittent
510(k) Number K132988
Device Name VITAL COUGH
Applicant
Lung Assist, Inc.
4655 Kirkwood Court
Boulder,  CO  80301
Applicant Contact LEWIS WARD
Correspondent
Lung Assist, Inc.
4655 Kirkwood Court
Boulder,  CO  80301
Correspondent Contact LEWIS WARD
Regulation Number868.5905
Classification Product Code
NHJ  
Date Received09/24/2013
Decision Date 03/28/2014
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Anesthesiology
510k Review Panel Anesthesiology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
-
-