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, Ion Specific, Potassium
510(k) Number K061107
Device Name DPC T60I KUSTI, MODEL 984248; DPC T60I, MODEL 984247
Applicant
Thermo Electron OY
Ratastie 2
Vantaa,  FI 01620
Applicant Contact PAIVI SORMUNEN
Correspondent
Thermo Electron OY
Ratastie 2
Vantaa,  FI 01620
Correspondent Contact PAIVI SORMUNEN
Regulation Number862.1600
Classification Product Code
CEM  
Subsequent Product Codes
CFR   CGZ   JGS   JIX   JJE  
JJY  
Date Received04/20/2006
Decision Date 08/08/2006
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Clinical Chemistry
510k Review Panel Clinical Chemistry
Statement Statement
FDA Review Decision Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
-
-