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, Hemodialysis, Access Recirculation Monitoring
510(k) Number K954003
Device Name COBE HEMODYNAMIC RECIRCULATION MONITOR
Applicant
Cobe Renal Care, Inc.
1201 Oak St.
Lakewood,  CO  80215
Applicant Contact MATTHEW M HULL
Correspondent
Cobe Renal Care, Inc.
1201 Oak St.
Lakewood,  CO  80215
Correspondent Contact MATTHEW M HULL
Regulation Number876.5820
Classification Product Code
MQS  
Date Received08/25/1995
Decision Date 02/06/1997
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
-
-