FDA 510(k) Application Details - K970029

Device Classification Name	Ophthalmoscope, Battery-Powered   More FDA Info for this Device
510(K) Number	K970029
Device Name	Ophthalmoscope, Battery-Powered
Applicant	KEELER INSTRUMENTS, INC. 456 PKWY. BROOMALL, PA 19008 US Other 510(k) Applications for this Company
Contact	EUGENE R VAN ARSDALE 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	01/03/1997
Decision Date	04/02/1997
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