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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 K063433
Device Name ULTRASONIC BIOMETER/PACHYMETER FOR OPTHALMOLOGY ODM 2100 AND ODM 2200
Applicant
Meda , Ltd.
5905 Fawn Lane
Cleveland,  OH  44141
Applicant Contact EDWARD A KROLL
Correspondent
Meda , Ltd.
5905 Fawn Lane
Cleveland,  OH  44141
Correspondent Contact EDWARD A KROLL
Regulation Number892.1560
Classification Product Code
IYO  
Subsequent Product Code
ITX  
Date Received11/13/2006
Decision Date 01/29/2007
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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