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510(k) K140096

HMICRO WIRED C-PATCH ELECTRODE, TRADE NAME SUBJECT TO CHANGE by Hmicro, Inc. — Product Code DRX

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 24, 2014
Date Received
January 14, 2014
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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