FDA 510(k) Application Details - K012414

Device Classification Name Electrocardiograph

  More FDA Info for this Device
510(K) Number K012414
Device Name Electrocardiograph
Applicant MERIDIAN MEDICAL TECHNOLOGIES, INC.
10240 OLD COLUMBIA RD.
COLUMBIA, MD 21046 US
Other 510(k) Applications for this Company
Contact JAMIL F LAHAM
Other 510(k) Applications for this Contact
Regulation Number 870.2340

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

  More FDA Info for this Product Code
Date Received 07/30/2001
Decision Date 03/06/2002
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