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 K923065
Device Name BAXTER PERSONAL CYCLER AUTOMMATED PERITONEAL DIAL
Applicant
Baxter Healthcare Corp
Route 120 And Wilson Rd.
Round Lake,  IL  60073
Applicant Contact DAVID C ROSS
Correspondent
Baxter Healthcare Corp
Route 120 And Wilson Rd.
Round Lake,  IL  60073
Correspondent Contact DAVID C ROSS
Regulation Number876.5630
Classification Product Code
FKX  
Date Received06/25/1992
Decision Date 03/04/1994
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Gastroenterology/Urology
510k Review Panel Gastroenterology/Urology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
Recalls CDRH Recalls
-
-