Search
Companies
Product Codes
Device Names
Contacts
Applications
Decisions
Contact
FDA 510(k) Application Details - K052077
Device Classification Name
Coil, Magnetic Resonance, Specialty
More FDA Info for this Device
510(K) Number
K052077
Device Name
Coil, Magnetic Resonance, Specialty
Applicant
ESAOTE, S.P.A.
7992 CASTLEWAY DRIVE
INDIANAPOLIS, IN 46250 US
Other 510(k) Applications for this Company
Contact
CARRI GRAHAM
Other 510(k) Applications for this Contact
Regulation Number
892.1000
More FDA Info for this Regulation Number
Classification Product Code
MOS
Other 510(k) Applications for this Device
More FDA Info for this Product Code
Date Received
08/01/2005
Decision Date
08/16/2005
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
RA - Radiology
Review Advisory Committee
RA - Radiology
Statement / Summary / Purged Status
Summary
Type
Special
Reviewed By Third Party
N
Expedited Review
Search
|
Companies
|
Product Codes
|
Device Names
|
Contacts
|
Applications
|
Decisions
|
Contact