FDA 510(k) Application Details - K003220

Device Classification Name Transmitters And Receivers, Electrocardiograph, Telephone

  More FDA Info for this Device
510(K) Number K003220
Device Name Transmitters And Receivers, Electrocardiograph, Telephone
Applicant CARD GUARD SCIENTIFIC SURVIVAL, LTD.
2 PEKERIS ST.
REHOVOT 76100 IL
Other 510(k) Applications for this Company
Contact LEONID TRACHTENBERG
Other 510(k) Applications for this Contact
Regulation Number 870.2920

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

  More FDA Info for this Product Code
Date Received 10/16/2000
Decision Date 11/08/2000
Decision SESE - SUBST EQUIV
Classification Advisory Committee CV - Cardiovascular
Review Advisory Committee CV - Cardiovascular
Statement / Summary / Purged Status Statement
Type Special
Reviewed By Third Party N
Expedited Review



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