FDA 510(k) Application Details - K123587

Device Classification Name	Ophthalmoscope, Battery-Powered   More FDA Info for this Device
510(K) Number	K123587
Device Name	Ophthalmoscope, Battery-Powered
Applicant	HEINE OPTOTECHNIK GMBH & CO. KG. KIENTALSTRASSE 7 HERRSCHING D-82211 DE Other 510(k) Applications for this Company
Contact	JOERG ROENNAU Other 510(k) Applications for this Contact
Regulation Number	886.1570   More FDA Info for this Regulation Number
Classification Product Code	HLJ Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	11/21/2012
Decision Date	03/22/2013
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	OP - Ophthalmic
Review Advisory Committee	OP - Ophthalmic
Statement / Summary / Purged Status	Summary
Type	Abbreviated
Reviewed By Third Party	Y
Expedited Review