FDA 510(k) Application Details - K141657

Device Classification Name Monitor, Ultrasonic, Nonfetal

  More FDA Info for this Device
510(K) Number K141657
Device Name Monitor, Ultrasonic, Nonfetal
Applicant THD SPA
VIA A. BONETTI 3/A
IMOLA, BO 40026 IT
Other 510(k) Applications for this Company
Contact MAURIZIO PANTALEONI
Other 510(k) Applications for this Contact
Regulation Number 892.1540

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

  More FDA Info for this Product Code
Date Received 06/20/2014
Decision Date 02/24/2015
Decision SESE - SUBST EQUIV
Classification Advisory Committee RA - Radiology
Review Advisory Committee RA - Radiology
Statement / Summary / Purged Status Summary
Type Traditional
Reviewed By Third Party N
Expedited Review



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