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 K961335
Device Name GEM PREMIER PLUS MODEL 5500
Applicant
Mallinckrodt Sensor Systems, Inc.
1590 Eisenhower Pl.
Ann Arbor,  MI  48108
Applicant Contact ANDREW C TAYLOR
Correspondent
Mallinckrodt Sensor Systems, Inc.
1590 Eisenhower Pl.
Ann Arbor,  MI  48108
Correspondent Contact ANDREW C TAYLOR
Regulation Number862.1120
Classification Product Code
CHL  
Subsequent Product Codes
CEM   GKF   JFP   JGS  
Date Received04/08/1996
Decision Date 06/28/1996
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Clinical Chemistry
510k Review Panel Clinical Chemistry
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
-
-