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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Ophthalmoscope, Ac-Powered
510(k) Number K942711
Device Name NEITZ HALOGEN OPHTHALMOSCOPE BXA-123
Applicant
NEITZ INSTRUMENTS COMPANY, LTD.
1050 CONNECTICUT AVE., N.W.
WASHINGTON,  DC 
Applicant Contact TRACY P BERNS
Correspondent
NEITZ INSTRUMENTS COMPANY, LTD.
1050 CONNECTICUT AVE., N.W.
WASHINGTON,  DC 
Correspondent Contact TRACY P BERNS
Regulation Number886.1570
Classification Product Code
HLI  
Date Received06/09/1994
Decision Date 08/05/1994
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Ophthalmic
510k Review Panel Ophthalmic
Type Traditional
Reviewed by Third Party No
Combination Product No
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