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 K001763
Device Name CRIT-LINE MONITOR III (CLM III)
Applicant
In-Line Diagnostics Corp.
695 N. 900 W.
Kaysville,  UT  84037
Applicant Contact MATTHEW L HAYNIE
Correspondent
In-Line Diagnostics Corp.
695 N. 900 W.
Kaysville,  UT  84037
Correspondent Contact MATTHEW L HAYNIE
Regulation Number876.5820
Classification Product Code
MQS  
Date Received06/12/2000
Decision Date 12/20/2000
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
-
-