FDA 510(k) Application Details - DEN130051

Device Classification Name	More FDA Info for this Device
510(K) Number	DEN130051
Device Name	PEDIATRIC VISION SCANNER
Applicant	REBISCAN, INC. 30 MOUNT AUBURN STREET, STE B CAMBRIDGE, MA 02138 US Other 510(k) Applications for this Company
Contact	JUSTIN G SHAKA Other 510(k) Applications for this Contact
Regulation Number	More FDA Info for this Regulation Number
Classification Product Code	PMW Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	12/13/2013
Decision Date	06/08/2016
Decision	DENG -
Classification Advisory Committee	OP - Ophthalmic
Review Advisory Committee	OP - Ophthalmic
Statement / Summary / Purged Status
Type	Direct
Reviewed By Third Party	N
Expedited Review