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 Electrode Measurement, Blood-Gases (Pco2, Po2) And Blood Ph
510(k) Number K935830
Device Name CIBA CORNING 248 PH/BLOOD GAS ANALYZER
Applicant
Ciba Corning Diagnostics Corp.
63 N. St.
Medfield,  MA  02052
Applicant Contact William J Pignato
Correspondent
Ciba Corning Diagnostics Corp.
63 N. St.
Medfield,  MA  02052
Correspondent Contact William J Pignato
Regulation Number862.1120
Classification Product Code
CHL  
Date Received12/07/1993
Decision Date 02/03/1994
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Clinical Chemistry
510k Review Panel Clinical Chemistry
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
-
-