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FDA 510(k) Application Details - DEN160020
Device Classification Name
More FDA Info for this Device
510(K) Number
DEN160020
Device Name
CipherOx CRI Tablet
Applicant
Flashback Technologies, Inc.
1215 Spruce Street, Suite 101
Boulder, CO 80302 US
Other 510(k) Applications for this Company
Contact
Gordon Van Dusen
Other 510(k) Applications for this Contact
Regulation Number
More FDA Info for this Regulation Number
Classification Product Code
PPW
Other 510(k) Applications for this Device
More FDA Info for this Product Code
Date Received
05/24/2016
Decision Date
12/21/2016
Decision
DENG -
Classification Advisory Committee
CV - Cardiovascular
Review Advisory Committee
CV - Cardiovascular
Statement / Summary / Purged Status
Type
Direct
Reviewed By Third Party
N
Expedited Review
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