FDA 510(k) Application Details - K993978

Device Classification Name	System, Imaging, Pulsed Echo, Ultrasonic   More FDA Info for this Device
510(K) Number	K993978
Device Name	System, Imaging, Pulsed Echo, Ultrasonic
Applicant	CAROLINA MEDICAL, INC. 157 INDUSTRIAL DR. KING, NC 27021 US Other 510(k) Applications for this Company
Contact	CARROLL L TURNER Other 510(k) Applications for this Contact
Regulation Number	892.1560   More FDA Info for this Regulation Number
Classification Product Code	IYO Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	11/24/1999
Decision Date	02/10/2000
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