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510(k) K930253

CARDIO2 CTCKE by Ergometrx, Inc. — Product Code ISD

K930253 is an FDA 510(k) premarket notification submitted by Ergometrx, Inc. for the device "CARDIO2 CTCKE". The FDA issued a decision of Substantially Equivalent on October 18, 1993. The device falls under product code ISD (Exerciser, Measuring), a Class II device regulated under 21 CFR 890.5360.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 18, 1993
Date Received
January 19, 1993
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Exerciser, Measuring
Device Class
Class II
Regulation Number
890.5360
Review Panel
PM
Submission Type

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FDA data resources