FDA 510(k) Application Details - K081429

Device Classification Name	Monitor, Ultrasonic, Nonfetal   More FDA Info for this Device
510(K) Number	K081429
Device Name	Monitor, Ultrasonic, Nonfetal
Applicant	THD SPA 5 TIMBER LN. NORTH READING, MA 01864 US Other 510(k) Applications for this Company
Contact	MAUREEN O'CONNELL 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	05/21/2008
Decision Date	07/30/2008
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