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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name System, Imaging, Pulsed Echo, Ultrasonic
510(k) Number K030770
Device Name OTI SCAN WITH TRANSDUCERS
Applicant
Ophthalmic Technologies, Inc.
377 Rt. 17 S
Hasbrouck,  NJ  07604
Applicant Contact GEORGE MYERS
Correspondent
Ophthalmic Technologies, Inc.
377 Rt. 17 S
Hasbrouck,  NJ  07604
Correspondent Contact GEORGE MYERS
Regulation Number892.1560
Classification Product Code
IYO  
Subsequent Product Code
ITX  
Date Received03/11/2003
Decision Date 03/27/2003
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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