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 Conductivity Rate, Urea Nitrogen
510(k) Number K990039
Device Name GAMBRO DQM 200
Applicant
Gambro Healthcare
1185 Oak St.
Lakewood,  CO  80215
Applicant Contact JEFFREY R SHIDEMAN
Correspondent
Gambro Healthcare
1185 Oak St.
Lakewood,  CO  80215
Correspondent Contact JEFFREY R SHIDEMAN
Regulation Number862.1770
Classification Product Code
LFP  
Date Received01/06/1999
Decision Date 01/27/2000
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
-
-