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510(k) K041954

DISPOSABLE MONITORING ELECTRODES by Shanghai Intco Electrode Manufacturing Co., Ltd. — Product Code DRX

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 15, 2004
Date Received
July 20, 2004
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 Shanghai Intco Electrode Manufacturing Co., Ltd.

  • K093327 — INTCO TAB ELECTRODE (May 10, 2010)

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