• 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 | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC | Inspections
 


New Search Back To Search Results
Device Classification Name electrode measurement, blood-gases (pco2, po2) and blood ph
510(k) Number K955793
Device Name IL BGGE BLOOD GAS WITH GLUCOSE SYSTEM
Original Applicant
INSTRUMENTATION LABORATORY CO.
180 hartwell road
bedford,  MA  01730
Original Contact betty j lane
Regulation Number862.1120
Classification Product Code
CHL  
Subsequent Product Codes
CEM   CGA   JGS  
Date Received12/22/1995
Decision Date 02/14/1996
Decision substantially equivalent (SESE)
Regulation Medical Specialty Clinical Chemistry
510k Review Panel Clinical Chemistry
Type Traditional
Reviewed by Third Party No
Combination Product No
-
-