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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Ophthalmoscope, Battery-Powered
510(k) Number K123587
Device Name HEINE MINI 3000 LED OPHTHALMOSCOPE
Applicant
HEINE OPTOTECHNIK GMBH & CO. KG.
KIENTALSTRASSE 7
HERRSCHING,  DE D-82211
Applicant Contact JOERG ROENNAU
Correspondent
TUV SUD AMERICA INC.
1775 OLD HIGHWAY 8 NW
NEW BRIGHTON,  MN  55112 -1891
Correspondent Contact OLAF TEICHERT
Regulation Number886.1570
Classification Product Code
HLJ  
Date Received11/21/2012
Decision Date 03/22/2013
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Ophthalmic
510k Review Panel Ophthalmic
Summary Summary
Type Abbreviated
Reviewed by Third Party Yes
Combination Product No
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