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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Tomography, Optical Coherence
510(k) Number K063191
Device Name HEIDELBERG RETINA ANGIOGRAPH 2/OPTICAL COHERENCE TOMOGRAPH, MODEL HRA 2/OCT
Applicant
Heidelberg Engineering
Tiergartenstrasse 15
Heidelberg,  DE 69121
Applicant Contact GERHARD ZINSER
Correspondent
Underwriters Laboratories, Inc.
455 E. Trimble Rd.
San Jose,  CA  95131
Regulation Number886.1570
Classification Product Code
OBO  
Date Received10/20/2006
Decision Date 10/31/2006
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Ophthalmic
510k Review Panel Ophthalmic
Summary Summary
Type Traditional
Reviewed by Third Party Yes
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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