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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, Tomography, Computed
510(k) Number K944013
Device Name CT PROSPEED FAMILY
Applicant
GE MEDICAL SYSTEMS
3000 N. GRANDVIEW BLVD.
WAUKESHA,  WI  53188
Applicant Contact LARRY A KROGER
Correspondent
GE MEDICAL SYSTEMS
3000 N. GRANDVIEW BLVD.
WAUKESHA,  WI  53188
Correspondent Contact LARRY A KROGER
Regulation Number892.1750
Classification Product Code
JAK  
Date Received08/16/1994
Decision Date 02/07/1995
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Type Traditional
Reviewed by Third Party No
Combination Product No
Recalls CDRH Recalls
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