Search
Companies
Product Codes
Device Names
Contacts
Applications
Decisions
Contact
FDA 510(k) Application Details - K070903
Device Classification Name
Transducer, Ultrasonic, Diagnostic
More FDA Info for this Device
510(K) Number
K070903
Device Name
Transducer, Ultrasonic, Diagnostic
Applicant
ESAOTE EUROPE B.V.
11460 N. MERIDIAN STREET
SUITE 150
CARMEL, IN 46032 US
Other 510(k) Applications for this Company
Contact
CARRI GRAHAM
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
04/02/2007
Decision Date
07/02/2007
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