FDA 510(k) Application Details - K983999

Device Classification Name	Ophthalmoscope, Ac-Powered   More FDA Info for this Device
510(K) Number	K983999
Device Name	Ophthalmoscope, Ac-Powered
Applicant	OPTOS PLC 555 THIRTEENTH ST. N.W. WASHINGTON, DC 20004 US Other 510(k) Applications for this Company
Contact	HOWARD M HOLSTEIN Other 510(k) Applications for this Contact
Regulation Number	886.1570   More FDA Info for this Regulation Number
Classification Product Code	HLI Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	11/09/1998
Decision Date	02/03/1999
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	OP - Ophthalmic
Review Advisory Committee	OP - Ophthalmic
Statement / Summary / Purged Status	Summary
Type	Traditional
Reviewed By Third Party	N
Expedited Review