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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Camera, Multi Format, Radiological
510(k) Number K971760
Device Name COLORPOINT OR PROFESSIONAL COLORPOINT
Applicant
Seiko Instruments USA, Inc.
1-8 Nakase,Mihama-Ku,Chiba-Shi
Chiba-Ken,  JP 271
Applicant Contact TOMOHIKO SAKAI
Correspondent
Seiko Instruments USA, Inc.
1-8 Nakase,Mihama-Ku,Chiba-Shi
Chiba-Ken,  JP 271
Correspondent Contact TOMOHIKO SAKAI
Regulation Number892.2040
Classification Product Code
LMC  
Date Received05/12/1997
Decision Date 10/01/1997
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Statement Statement
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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