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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 K142486
Device Name HEINE BETA 200, HEINE BETA 200 S, HEINE K 180
Applicant
Heine Optotechnik GmbH & Co. KG
Kientalstr. 7
Herrsching,  DE 82211
Applicant Contact Bettina Seim
Correspondent
Heine USA , Ltd.
10 Innovation Way
Dover,  NH  03820
Correspondent Contact Belinda Labourdette
Regulation Number886.1570
Classification Product Code
HLJ  
Date Received09/04/2014
Decision Date 05/18/2015
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Ophthalmic
510k Review Panel Ophthalmic
Summary Summary
Type Abbreviated
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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