FDA 510(k) Application Details - K153426

Device Classification Name Oximeter, Tissue Saturation

  More FDA Info for this Device
510(K) Number K153426
Device Name Oximeter, Tissue Saturation
Applicant MODULATED IMAGING, INC.
17151 GILLETTE AVE
IRVINE, CA 92604 US
Other 510(k) Applications for this Company
Contact DAVID CUCCIA
Other 510(k) Applications for this Contact
Regulation Number 870.2700

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

  More FDA Info for this Product Code
Date Received 11/25/2015
Decision Date 12/21/2016
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