FDA 510(k) Application Details - K022023

Device Classification Name Monitor, Esophageal Motility, And Tube

  More FDA Info for this Device
510(K) Number K022023
Device Name Monitor, Esophageal Motility, And Tube
Applicant CLINICAL INNOVATIONS, INC.
747 WEST 4170 SOUTH
MURRAY, UT 84123 US
Other 510(k) Applications for this Company
Contact WILLIAM DEAN WALLACE
Other 510(k) Applications for this Contact
Regulation Number 876.1725

  More FDA Info for this Regulation Number
Classification Product Code KLA
Other 510(k) Applications for this Device

  More FDA Info for this Product Code
Date Received 06/20/2002
Decision Date 01/07/2003
Decision SESE - SUBST EQUIV
Classification Advisory Committee GU - Gastroenterology & Urology
Review Advisory Committee GU - Gastroenterology & Urology
Statement / Summary / Purged Status Summary
Type Traditional
Reviewed By Third Party N
Expedited Review



Search | Companies | Product Codes | Device Names | Contacts | Applications | Decisions | Contact