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FDA 510(k) Application Details - K100849
Device Classification Name
System, X-Ray, Angiographic
More FDA Info for this Device
510(K) Number
K100849
Device Name
System, X-Ray, Angiographic
Applicant
SYNC-RX LTD
555 ZANG ST
SUITE 100
LAKEWOOD, CO 80228 US
Other 510(k) Applications for this Company
Contact
A ANSELMO
Other 510(k) Applications for this Contact
Regulation Number
892.1600
More FDA Info for this Regulation Number
Classification Product Code
IZI
Other 510(k) Applications for this Device
More FDA Info for this Product Code
Date Received
03/26/2010
Decision Date
05/21/2010
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
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