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 K042980
Device Name HOSPIRA GEMSTAR INFUSION PUMP SYSTEM, HOSPIRA GEMSTAR CONNECT SOFTWARE
Applicant
HOSPIRA, INC.
275 N. FIELD DR., BLDG. H-2
D-389
LAKE FOREST,  IL  60045 -5045
Applicant Contact PATRICIA MELERSKI
Correspondent
HOSPIRA, INC.
275 N. FIELD DR., BLDG. H-2
D-389
LAKE FOREST,  IL  60045 -5045
Correspondent Contact PATRICIA MELERSKI
Regulation Number880.5725
Classification Product Code
FRN  
Date Received10/29/2004
Decision Date 11/17/2004
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General Hospital
510k Review Panel General Hospital
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
Recalls CDRH Recalls
-
-