FDA 510(k) Application Details - K003937

Device Classification Name Aid, Cardiopulmonary Resuscitation

  More FDA Info for this Device
510(K) Number K003937
Device Name Aid, Cardiopulmonary Resuscitation
Applicant MEDTEQ INNOVATIONS PTY LTD
7361 CALHOUN PLACE, SUITE 500
ROCKVILLE, MD 20855-2765 US
Other 510(k) Applications for this Company
Contact EDUARDO MARCH
Other 510(k) Applications for this Contact
Regulation Number 870.5200

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

  More FDA Info for this Product Code
Date Received 12/20/2000
Decision Date 06/06/2001
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