FDA 510(k) Application Details - K972152

Device Classification Name	Transducer, Ultrasonic, Diagnostic   More FDA Info for this Device
510(K) Number	K972152
Device Name	Transducer, Ultrasonic, Diagnostic
Applicant	DEVMED CORP. 2655 NORTH OCEAN DR. SINGER ISLAND, FL 33404 US Other 510(k) Applications for this Company
Contact	GREG WIITA Other 510(k) Applications for this Contact
Regulation Number	892.1570   More FDA Info for this Regulation Number
Classification Product Code	ITX Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	06/09/1997
Decision Date	08/15/1997
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