FDA 510(k) Application Details - K974445

Device Classification Name Electrode, Electrocardiograph

  More FDA Info for this Device
510(K) Number K974445
Device Name Electrode, Electrocardiograph
Applicant 3M HEALTH CARE
3M CENTER, BLDG. 275-3E-08
P.O. BOX 33275
ST. PAUL, MN 55133-1000 US
Other 510(k) Applications for this Company
Contact LINDA JOHNSEN
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 11/25/1997
Decision Date 07/26/1998
Decision SESE - SUBST EQUIV
Classification Advisory Committee CV - Cardiovascular
Review Advisory Committee CV - Cardiovascular
Statement / Summary / Purged Status Summary
Type Traditional
Reviewed By Third Party N
Expedited Review



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