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510(k) K781152

ELECTROCARDIOGRAPHIC ECG RECORDER by Cardio-Dynamics Laboratories, Inc. — Product Code DSM

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 31, 1978
Date Received
July 10, 1978
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Alarm, Leakage Current, Portable
Device Class
Class I
Regulation Number
870.2640
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)
  • K770988 — FOAM ECG ELECTRODE, 2060 AND 2061 (June 14, 1977)