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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
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