FDA 510(k) Application Details - K071047

Device Classification Name System,Network And Communication,Physiological Monitors

  More FDA Info for this Device
510(K) Number K071047
Device Name System,Network And Communication,Physiological Monitors
Applicant MASIMO CORPORATION
40 PARKER
IRVINE, CA 92618 US
Other 510(k) Applications for this Company
Contact MARGUERITE THOMLINSON
Other 510(k) Applications for this Contact
Regulation Number 870.2300

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

  More FDA Info for this Product Code
Date Received 04/13/2007
Decision Date 06/08/2007
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