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, Elastomeric
510(k) Number K071222
Device Name INFUSOR SV AND LV ELASTOMERIC INFUSION DEVICES
Applicant
BAXTER HEALTHCARE CORP.
1620 WAUKEGAN ROAD
MCGAW PARK,  IL  60085
Applicant Contact NANETTE HEDDEN
Correspondent
BAXTER HEALTHCARE CORP.
1620 WAUKEGAN ROAD
MCGAW PARK,  IL  60085
Correspondent Contact NANETTE HEDDEN
Regulation Number880.5725
Classification Product Code
MEB  
Date Received05/02/2007
Decision Date 05/25/2007
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
Predetermined Change
Control Plan Authorized		 No
Recalls CDRH Recalls
-
-