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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 Ter.
Findley,  MN  55432
Applicant Contact CONSTANCE G BUNDY
Correspondent
Ergometrx, Inc.
6470 Riverview Ter.
Findley,  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
Predetermined Change
Control Plan Authorized		 No
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