FDA 510(k) Application Details - K131959

Device Classification Name	Ophthalmoscope, Battery-Powered   More FDA Info for this Device
510(K) Number	K131959
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	MANFRED BARTSCH-TITTMANN 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	06/27/2013
Decision Date	03/07/2014
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	N
Expedited Review