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 K021988
Device Name MEDRAD CONTINUUM MR COMPATIBLE INFUSION SYSTEM
Applicant
Medrad, Inc.
One Medrad Dr.
Indianola,  PA  15051
Applicant Contact LORRAINE R FREDES
Correspondent
Citech
5200 Butler Pike
Plymouth Meeting,  PA  19462
Correspondent Contact ROBERT MOSENKIS
Regulation Number880.5725
Classification Product Code
FRN  
Subsequent Product Code
FPA  
Date Received06/18/2002
Decision Date 08/29/2002
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General Hospital
510k Review Panel General Hospital
Statement Statement
Type Abbreviated
Reviewed by Third Party Yes
Combination Product No
Predetermined Change
Control Plan Authorized		 No
Recalls CDRH Recalls
-
-