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 generator, oxygen, portable
510(k) Number K981078
Device Name TRANSTRACHEAL AUGMENTED VENTILATION OXYGEN CONCENTRATOR MODEL NUMBER TTAV 1000
Applicant
TRANSTRACHEAL SYSTEMS
4655 KIRKWOOD COURT
BOULDER,  CO  80301
Applicant Contact LEWIS WARD
Correspondent
TRANSTRACHEAL SYSTEMS
4655 KIRKWOOD COURT
BOULDER,  CO  80301
Correspondent Contact LEWIS WARD
Regulation Number868.5440
Classification Product Code
CAW  
Date Received03/24/1998
Decision Date 07/23/1998
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Anesthesiology
510k Review Panel Anesthesiology
Statement Statement
Type Traditional
Reviewed by Third Party No
Combination Product No
-
-