FDA 510(k) Application Details - K093495

Device Classification Name	Ophthalmoscope, Battery-Powered   More FDA Info for this Device
510(K) Number	K093495
Device Name	Ophthalmoscope, Battery-Powered
Applicant	AMERICAN DIAGNOSTIC CORP. 55 COMMERCE DR. HAUPPAUGE, NY 11788 US Other 510(k) Applications for this Company
Contact	MICHAEL FALCO 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	11/10/2009
Decision Date	11/19/2010
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	OP - Ophthalmic
Review Advisory Committee	OP - Ophthalmic
Statement / Summary / Purged Status	Statement
Type	Traditional
Reviewed By Third Party	N
Expedited Review