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510(k) K770988

FOAM ECG ELECTRODE, 2060 AND 2061 by Cardio-Dynamics Laboratories, Inc. — Product Code DRX

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 14, 1977
Date Received
May 31, 1977
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Electrode, Electrocardiograph
Device Class
Class II
Regulation Number
870.2360
Review Panel
CV
Submission Type

Other clearances by Cardio-Dynamics Laboratories, Inc.

  • K781911 — ECG ANALYZER, HIGH SPEED (November 30, 1978)
  • K781514 — ECG ELECTRODE, 2021, 2022, 2032, 2033 (October 17, 1978)
  • K781152 — ELECTROCARDIOGRAPHIC ECG RECORDER (August 31, 1978)

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  • K100315 — 12 LEAD GLOVE (April 23, 2010)
  • K092744 — NEONATAL ECG ELECTRODE, M203KEN (December 10, 2009)
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