Search
Companies
Product Codes
Device Names
Contacts
Applications
Decisions
Contact
FDA 510(k) Application Details - K083321
Device Classification Name
Display, Cathode-Ray Tube, Medical
More FDA Info for this Device
510(K) Number
K083321
Device Name
Display, Cathode-Ray Tube, Medical
Applicant
CURLVIEW IGT, LLC
1242 CHESTNUT ST.
NEWTON, MA 02464 US
Other 510(k) Applications for this Company
Regulation Number
870.2450
More FDA Info for this Regulation Number
Classification Product Code
DXJ
Other 510(k) Applications for this Device
More FDA Info for this Product Code
Date Received
11/11/2008
Decision Date
11/26/2008
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
Y
Expedited Review
Search
|
Companies
|
Product Codes
|
Device Names
|
Contacts
|
Applications
|
Decisions
|
Contact