FDA 510(k) Application Details - K032736

Device Classification Name Transmitters And Receivers, Electrocardiograph, Telephone

  More FDA Info for this Device
510(K) Number K032736
Device Name Transmitters And Receivers, Electrocardiograph, Telephone
Applicant AEROTEL MEDICAL SYSTEMS (1998) LTD.
377 ROUTE 17
HASBROUCK HEIGHTS, NJ 07604 US
Other 510(k) Applications for this Company
Contact GEORGE MYERS
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 09/04/2003
Decision Date 10/03/2003
Decision SESE - SUBST EQUIV
Classification Advisory Committee CV - Cardiovascular
Review Advisory Committee CV - Cardiovascular
Statement / Summary / Purged Status Summary
Type Special
Reviewed By Third Party N
Expedited Review



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