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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 K022919
Device Name SMART BREATH RESPIRATORY COMPENSATION OPTION
Applicant
GE Medical Systems
P.O. 414
Milwaukee,  WI  53201
Applicant Contact LARRY A KROGER
Correspondent
Tuv Rheinland of North America, Inc.
12 Commerce Rd.
Newton,  CT  06470
Correspondent Contact HEINZ JOERG STENEBERG
Regulation Number892.1750
Classification Product Code
JAK  
Date Received09/04/2002
Decision Date 09/19/2002
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Summary Summary
Type Traditional
Reviewed by Third Party Yes
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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