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510(k) K895460

CONCENTRIC ELECTRODE TYPE #13R01, 13R02 by Dantec Electronics, Inc. — Product Code IKT

K895460 is an FDA 510(k) premarket notification submitted by Dantec Electronics, Inc. for the device "CONCENTRIC ELECTRODE TYPE #13R01, 13R02". The FDA issued a decision of Substantially Equivalent on June 18, 1990. The device falls under product code IKT (Electrode, Needle, Diagnostic Electromyograph), a Class II device regulated under 21 CFR 890.1385. Dantec Electronics, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 18, 1990
Date Received
September 6, 1989
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Electrode, Needle, Diagnostic Electromyograph
Device Class
Class II
Regulation Number
890.1385
Review Panel
NE
Submission Type

Other clearances by Dantec Electronics, Inc.

  • K894911 — SENSORY NEEDLE ELECTRODE DNE 111-115,116-117,118 (May 14, 1990)
  • K884915 — DANTEC 22K60/61/62 CATHETER TIP TRANSDUCER (October 4, 1989)
  • K881915 — DANTEC MAGNETIC STIMULATOR (October 17, 1988)
  • K874758 — DANTEC 13L40 ST. MARKS'S PUDENDAL ELECTRODE (April 14, 1988)
  • K874759 — 13L81 DISPOSABLE SPHINCTER ELECTRODE, 13L33 CABLE (April 14, 1988)
  • K874735 — DANTEC 13L35/36/37 STIM. AND RECORDING ELECTRODE (January 22, 1988)
  • K870567 — EVOPORT 300 (October 6, 1987)
  • K872106 — DANTEC COUNTERPOINT (September 10, 1987)
  • K860368 — URDYN 5000 (UROFLOWMETER) (April 23, 1986)
  • K853119 — URODYN 1000 (October 4, 1985)

Other clearances for product code IKT

  • K253581 — Disposable Concentric Needle Electrode 0.30x25mm Red (TE/B50700-001); Disposable (March 15, 2026)
  • K173815 — Allergan Botox Needle Electrode (June 29, 2018)
  • K161430 — Myoject Luer Lock Needle Electrode (March 2, 2017)
  • K152984 — Disposable Concentric Needle electrodes, Disposable Monopolar Needle electrodes, (June 3, 2016)
  • K143433 — Dantec DCN Disposable Concentric Needle Electrodes-25mm, Dantec DCN Disposable C (August 28, 2015)
  • K120342 — EMG RECORDING ELECTRODE ASSEMBLY (June 22, 2012)
  • K112034 — TECA ELITE DISPOSABLE CONCENTRIC NEEDLES (August 12, 2011)
  • K111131 — TECA (TM) ELITE DISPOSABLE MONOPOLAR NEEDLES (June 17, 2011)
  • K092973 — DISPOSABLE AND REUSABLE CONCENTRIC NEEDLES / DISPOSABLE AND REUSABLE MONOPOLAR N (October 7, 2010)
  • K093825 — AMBU NEUROLINE DISPOSABLE INOJECT NEEDLE ELECTRODE (January 13, 2010)

FDA data resources