• 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 K950397
Device Name SYSTEM 22 VALVE
Applicant
TURNKEY INTERGRATION USA, INC.
6060 CASTLEWAY DR. WEST
SUITE 236
INDIANAPOLIS,  IN  46250 -1290
Applicant Contact DOUGLAS W STUART
Correspondent
TURNKEY INTERGRATION USA, INC.
6060 CASTLEWAY DR. WEST
SUITE 236
INDIANAPOLIS,  IN  46250 -1290
Correspondent Contact DOUGLAS W STUART
Regulation Number868.5965
Classification Product Code
BYE  
Date Received02/01/1995
Decision Date 04/14/1995
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Anesthesiology
510k Review Panel Anesthesiology
Type Traditional
Reviewed by Third Party No
Combination Product No
-
-