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510(k) K821434

EKG (ECG) ELECTRODES by Dupaco, Inc. — Product Code DRX

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 30, 1982
Date Received
May 12, 1982
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

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  • K093327 — INTCO TAB ELECTRODE (May 10, 2010)
  • K100315 — 12 LEAD GLOVE (April 23, 2010)
  • K092744 — NEONATAL ECG ELECTRODE, M203KEN (December 10, 2009)
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