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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name System, X-Ray, Fluoroscopic, Image-Intensified
510(k) Number K842217
Device Name IDAS DIGITAL FLUOROSCOPIC IMAGINS SYS
Applicant
Micro Consultants, Inc.
3290 W. Bayshore Rd.
Palo Alto,  CA  94303
Applicant Contact NATHAN SCHNEIDER
Correspondent
Micro Consultants, Inc.
3290 W. Bayshore Rd.
Palo Alto,  CA  94303
Correspondent Contact NATHAN SCHNEIDER
Regulation Number892.1650
Classification Product Code
JAA  
Date Received06/04/1984
Decision Date 11/08/1984
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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