FDA 510(k) Application Details - K053425

Device Classification Name	Ophthalmoscope, Battery-Powered   More FDA Info for this Device
510(K) Number	K053425
Device Name	Ophthalmoscope, Battery-Powered
Applicant	PRECISION OPTICS CORP. 22 EAST BROADWAY GARDNER, MA 01440-3338 US Other 510(k) Applications for this Company
Contact	ERWIN HEIDER 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	12/08/2005
Decision Date	01/09/2006
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	Y
Expedited Review