FDA 510(k) Application Details - K970125

Device Classification Name Electrode, Electrocardiograph

  More FDA Info for this Device
510(K) Number K970125
Device Name Electrode, Electrocardiograph
Applicant CONTOUR MEDICAL TECHNOLOGY, INC.
144 SOUTHWAY BLVD.
LAVERGNE, TN 37086 US
Other 510(k) Applications for this Company
Contact JOSH TRANTUM
Other 510(k) Applications for this Contact
Regulation Number 870.2360

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

  More FDA Info for this Product Code
Date Received 01/14/1997
Decision Date 03/04/1997
Decision SESE - SUBST EQUIV
Classification Advisory Committee CV - Cardiovascular
Review Advisory Committee CV - Cardiovascular
Statement / Summary / Purged Status Statement
Type Traditional
Reviewed By Third Party N
Expedited Review



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