Search
Companies
Product Codes
Device Names
Contacts
Applications
Decisions
Contact
FDA 510(k) Application Details - K953634
Device Classification Name
System, Imaging, Pulsed Echo, Ultrasonic
More FDA Info for this Device
510(K) Number
K953634
Device Name
System, Imaging, Pulsed Echo, Ultrasonic
Applicant
SHIMADZU MEDICAL SYSTEMS
20101 SOUTH VERMONT AVE.
TORRANCE, CA 90502-1328 US
Other 510(k) Applications for this Company
Contact
YASHUHARU ISHII
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
08/02/1995
Decision Date
02/13/1996
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
Search
|
Companies
|
Product Codes
|
Device Names
|
Contacts
|
Applications
|
Decisions
|
Contact