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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 K880065
Device Name NIDEK UP-2000
Applicant
Nidek, Inc.
2460 Embarcadero Way
P.O.Box 50488
Palo Alto,  CA  94303
Applicant Contact CARL R JORDAN
Correspondent
Nidek, Inc.
2460 Embarcadero Way
P.O.Box 50488
Palo Alto,  CA  94303
Correspondent Contact CARL R JORDAN
Regulation Number892.1560
Classification Product Code
IYO  
Date Received01/07/1988
Decision Date 03/15/1988
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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