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 K111275
Device Name CADD SOLIS VIP AMBULATORY INFUSION PUMP AND CADD SOLIS MEDICATION SAFETY SOFTWARE
Applicant
SMITHS MEDICAL ASD, INC.
1265 GREY FOX ROAD
ARDEN HILLS,  MN  55112
Applicant Contact JULIE TAPPER
Correspondent
SMITHS MEDICAL ASD, INC.
1265 GREY FOX ROAD
ARDEN HILLS,  MN  55112
Correspondent Contact JULIE TAPPER
Regulation Number880.5725
Classification Product Code
FRN  
Date Received05/06/2011
Decision Date 02/01/2013
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
-
-