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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 K902411
Device Name NIDEK US-2500 W/BIOMETRY UNIT US-2520
Applicant
Nidek, Inc.
2460 Embarcadero Way
P.O.Box 50488
Palo Alto,  CA  94303
Applicant Contact KEN KATO
Correspondent
Nidek, Inc.
2460 Embarcadero Way
P.O.Box 50488
Palo Alto,  CA  94303
Correspondent Contact KEN KATO
Regulation Number892.1560
Classification Product Code
IYO  
Date Received05/31/1990
Decision Date 10/09/1990
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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