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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Assembly, Tube Housing, X-Ray, Diagnostic
510(k) Number K882323
Device Name MEICOR X-RAY TUBE, MODELS MC1000, MC1500, MC2000
Applicant
Meicor, Inc.
6624 Owens Dr.
Pleasanton,  CA  94566
Applicant Contact ROBERT T BOCK
Correspondent
Meicor, Inc.
6624 Owens Dr.
Pleasanton,  CA  94566
Correspondent Contact ROBERT T BOCK
Regulation Number892.1760
Classification Product Code
ITY  
Date Received06/06/1988
Decision Date 06/30/1988
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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