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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Tube Mount, X-Ray, Diagnostic
510(k) Number K940442
Device Name MPR-814
Applicant
Xri, Inc.
2882-A Walnut Ave.
Tustin,  CA  92680
Applicant Contact ROBERT DOUBLEDEE
Correspondent
Xri, Inc.
2882-A Walnut Ave.
Tustin,  CA  92680
Correspondent Contact ROBERT DOUBLEDEE
Regulation Number892.1770
Classification Product Code
IYB  
Date Received02/01/1994
Decision Date 06/09/1994
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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