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510(k) K070270

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

K070270 is an FDA 510(k) premarket notification submitted by Kirchner & Wilhelm GmbH + Co.Kg for the device "PICCOLIGHT E50,PICCOLIGHT E56,EUROLIGHT E10, EUROLIGHT E30, AND EUROLIGHT E36". The FDA issued a decision of Substantially Equivalent on November 5, 2007. The device falls under product code HLJ (Ophthalmoscope, Battery-Powered), a Class II device regulated under 21 CFR 886.1570.

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

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FDA data resources