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 pump, infusion
510(k) Number K133801
Device Name BAXTER SIGMA SPECTRUM INFUSION PUMP WITH MASTER DRUG LIBRARY
Applicant
BAXTER HEALTHCARE CORPORATION
32650 N. WILSON ROAD
ROUND LAKE,  IL  60073
Applicant Contact THOMAS SAMPOGNA
Correspondent
BAXTER HEALTHCARE CORPORATION
32650 N. WILSON ROAD
ROUND LAKE,  IL  60073
Correspondent Contact THOMAS SAMPOGNA
Regulation Number880.5725
Classification Product Code
FRN  
Subsequent Product Code
PHC  
Date Received12/13/2013
Decision Date 05/07/2014
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General Hospital
510k Review Panel General Hospital
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Recalls CDRH Recalls
-
-