510(k) K070270

PICCOLIGHT E50,PICCOLIGHT E56,EUROLIGHT E10, EUROLIGHT E30, AND EUROLIGHT E36 by Kirchner & Wilhelm GmbH + Co.Kg — Product Code HLJ

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
November 5, 2007
Date Received
January 29, 2007
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Ophthalmoscope, Battery-Powered
Device Class
Class II
Regulation Number
886.1570
Review Panel
OP
Submission Type