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510(k) K926233

CARDIO2 CYCLE by Ergometrix, Inc. — Product Code KRI

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 4, 1993
Date Received
December 11, 1992
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Accessory Equipment, Cardiopulmonary Bypass
Device Class
Class I
Regulation Number
870.4200
Review Panel
CV
Submission Type

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