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 K002380
Device Name INFUSOR SV, INFUSOR LV, BAXTER PAIN MANAGEMENT SYSTEM
Applicant
Baxter Healthcare Corp
Rt. 120 & Wilson Rd.
Round Lake,  IL  60073
Applicant Contact VICKI L DREWS
Correspondent
Baxter Healthcare Corp
Rt. 120 & Wilson Rd.
Round Lake,  IL  60073
Correspondent Contact VICKI L DREWS
Regulation Number880.5725
Classification Product Code
FRN  
Subsequent Product Code
MEB  
Date Received08/04/2000
Decision Date 09/05/2000
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General Hospital
510k Review Panel General Hospital
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
-
-