Search
Companies
Product Codes
Device Names
Contacts
Applications
Decisions
Contact
FDA 510(k) Application Details - K130594
Device Classification Name
Computer, Diagnostic, Programmable
More FDA Info for this Device
510(K) Number
K130594
Device Name
Computer, Diagnostic, Programmable
Applicant
ST. JUDE MEDICAL
One St. Jude Medical Drive
St. Paul, MN 55117 US
Other 510(k) Applications for this Company
Contact
DONNA R LUNAK
Other 510(k) Applications for this Contact
Regulation Number
870.1425
More FDA Info for this Regulation Number
Classification Product Code
DQK
Other 510(k) Applications for this Device
More FDA Info for this Product Code
Date Received
03/07/2013
Decision Date
05/03/2013
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
CV - Cardiovascular
Review Advisory Committee
CV - Cardiovascular
Statement / Summary / Purged Status
Summary
Type
Traditional
Reviewed By Third Party
N
Expedited Review
Search
|
Companies
|
Product Codes
|
Device Names
|
Contacts
|
Applications
|
Decisions
|
Contact