Search
Companies
Product Codes
Device Names
Contacts
Applications
Decisions
Contact
FDA 510(k) Application Details - K093738
Device Classification Name
System, Nuclear Magnetic Resonance Imaging
More FDA Info for this Device
510(K) Number
K093738
Device Name
System, Nuclear Magnetic Resonance Imaging
Applicant
MEDTEC, INC.
102 FIRST STREET SOUTH
KALONA, IA 52247-9589 US
Other 510(k) Applications for this Company
Contact
JAMES LEONG
Other 510(k) Applications for this Contact
Regulation Number
892.1000
More FDA Info for this Regulation Number
Classification Product Code
LNH
Other 510(k) Applications for this Device
More FDA Info for this Product Code
Date Received
12/04/2009
Decision Date
05/14/2010
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
Y
Expedited Review
Search
|
Companies
|
Product Codes
|
Device Names
|
Contacts
|
Applications
|
Decisions
|
Contact