Search
Companies
Product Codes
Device Names
Contacts
Applications
Decisions
Contact
FDA 510(k) Application Details - K113184
Device Classification Name
System, Imaging, Pulsed Doppler, Ultrasonic
More FDA Info for this Device
510(K) Number
K113184
Device Name
System, Imaging, Pulsed Doppler, Ultrasonic
Applicant
TELEMED
DARIARUS IR GIRENO STREET 42
VILNIUS LT-02189 LT
Other 510(k) Applications for this Company
Contact
YURY SOKOLOV
Other 510(k) Applications for this Contact
Regulation Number
892.1550
More FDA Info for this Regulation Number
Classification Product Code
IYN
Other 510(k) Applications for this Device
More FDA Info for this Product Code
Date Received
10/28/2011
Decision Date
01/26/2012
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
Search
|
Companies
|
Product Codes
|
Device Names
|
Contacts
|
Applications
|
Decisions
|
Contact