FDA 510(k) Application Details - K955893

Device Classification Name	Transducer, Ultrasonic, Diagnostic   More FDA Info for this Device
510(K) Number	K955893
Device Name	Transducer, Ultrasonic, Diagnostic
Applicant	AMEDIC AB TUREBERGSVAGEN 5 SOLLENTUNA 191 47 SE Other 510(k) Applications for this Company
Contact	GINA AZARIC 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	12/15/1995
Decision Date	12/30/1997
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	RA - Radiology
Review Advisory Committee	RA - Radiology
Statement / Summary / Purged Status	Statement
Type	Traditional
Reviewed By Third Party	N
Expedited Review