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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Exerciser, Measuring
510(k) Number K930253
Device Name CARDIO2 CTCKE
Applicant
ERGOMETRX, INC.
6470 RIVERVIEW TERRACE
MINNEAPOLIS,  MN  55432
Applicant Contact CONSTANCE G BUNDY
Correspondent
ERGOMETRX, INC.
6470 RIVERVIEW TERRACE
MINNEAPOLIS,  MN  55432
Correspondent Contact CONSTANCE G BUNDY
Regulation Number890.5360
Classification Product Code
ISD  
Subsequent Product Code
BXB  
Date Received01/19/1993
Decision Date 10/18/1993
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Physical Medicine
510k Review Panel Physical Medicine
Type Traditional
Reviewed by Third Party No
Combination Product No
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