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510(k) K090180

TENDER-TRODE PREWIRED PEDIATRIC ECG ELECTRODE by Vermed, Inc. — Product Code DRX

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 17, 2009
Date Received
January 23, 2009
Clearance Type
Abbreviated
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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