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510(k) K072276

SUBDERMAL NEEDLE ELECTRODES by Xian Friendship Electronics Co., Ltd. — Product Code GXZ

K072276 is an FDA 510(k) premarket notification submitted by Xian Friendship Electronics Co., Ltd. for the device "SUBDERMAL NEEDLE ELECTRODES". The FDA issued a decision of Substantially Equivalent on May 16, 2008. The device falls under product code GXZ (Electrode, Needle), a Class II device regulated under 21 CFR 882.1350.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 16, 2008
Date Received
August 15, 2007
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Electrode, Needle
Device Class
Class II
Regulation Number
882.1350
Review Panel
NE
Submission Type

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  • K161566 — DMS Disposable Subdermal Needle Electrodes (December 21, 2016)
  • K142470 — E-Shield Multi-paried Subdermal Needle Electrodes (November 5, 2014)
  • K140200 — E-SHIELD MULTI-PAIRED SUBDERMAL NEEDLE ELECTRODES (July 18, 2014)
  • K130220 — MR CONDITIONAL PRESSON ELECTRODE (July 22, 2013)

FDA data resources