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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, Mobile
510(k) Number K931200
Device Name BATTERY PACKS (VARIOUS MODELS)
Applicant
Access / God Loves You
P.O. Box 1630
Castle Rock,  CO  80104
Applicant Contact DAWN REID
Correspondent
Access / God Loves You
P.O. Box 1630
Castle Rock,  CO  80104
Correspondent Contact DAWN REID
Regulation Number892.1720
Classification Product Code
IZL  
Date Received03/09/1993
Decision Date 07/13/1993
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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