Search
Companies
Product Codes
Device Names
Contacts
Applications
Decisions
Contact
FDA 510(k) Application Details - K100102
Device Classification Name
More FDA Info for this Device
510(K) Number
K100102
Device Name
CS-SERIES-FP
Applicant
OMEGA MEDICAL IMAGING, INC.
675 HICKMAN CIRCLE
SANFORD, FL 32771 US
Other 510(k) Applications for this Company
Contact
James Princehorn
Other 510(k) Applications for this Contact
Regulation Number
More FDA Info for this Regulation Number
Classification Product Code
OWB
Other 510(k) Applications for this Device
More FDA Info for this Product Code
Date Received
01/13/2010
Decision Date
08/31/2010
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
N
Expedited Review
Search
|
Companies
|
Product Codes
|
Device Names
|
Contacts
|
Applications
|
Decisions
|
Contact