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 attachment, breathing, positive end expiratory pressure
510(k) Number K050918
Device Name KOO AMERICAS VALVE PEEP, MODEL KM-809
Applicant
KOO AMERICAS, INC.
1050-C NINE NORTH DRIVE
ALPHARETTA,  GA  30004
Applicant Contact WILLIAM SLEVIN
Correspondent
KOO AMERICAS, INC.
1050-C NINE NORTH DRIVE
ALPHARETTA,  GA  30004
Correspondent Contact WILLIAM SLEVIN
Regulation Number868.5965
Classification Product Code
BYE  
Date Received04/12/2005
Decision Date 06/06/2005
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Anesthesiology
510k Review Panel Anesthesiology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
-
-