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 system, peritoneal, automatic delivery
510(k) Number K002892
FOIA Releasable 510(k) K002892
Device Name FRSENIUS PD IQCARD CYCLER
Applicant
FRESENIUS MEDICAL CARE NORTH AMERICA
95 HAYDEN AVE.
LEXINGTON,  MA  02420 -9192
Applicant Contact ARTHUR EILINSFEILD
Correspondent
FRESENIUS MEDICAL CARE NORTH AMERICA
95 HAYDEN AVE.
LEXINGTON,  MA  02420 -9192
Correspondent Contact ARTHUR EILINSFEILD
Regulation Number876.5630
Classification Product Code
FKX  
Date Received09/15/2000
Decision Date 04/05/2001
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Gastroenterology/Urology
510k Review Panel Gastroenterology/Urology
Type Traditional
Reviewed by Third Party No
Combination Product No
Recalls CDRH Recalls
-
-