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 Gas, Calibration (Specified Concentration)
510(k) Number K932874
Device Name BLOOD GAS MIXTURE
Applicant
Tri-Gas, Inc.
2200 Houston Ave.
Houston,  TX  77007
Applicant Contact GERALD SMITH
Correspondent
Tri-Gas, Inc.
2200 Houston Ave.
Houston,  TX  77007
Correspondent Contact GERALD SMITH
Regulation Number868.6400
Classification Product Code
BXK  
Date Received06/14/1993
Decision Date 01/27/1994
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Anesthesiology
510k Review Panel Anesthesiology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
-
-