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510(k) K102166

ELECTRO INTERSTITIAL SCAN by Ld Technology, LLC — Product Code GZO

K102166 is an FDA 510(k) premarket notification submitted by Ld Technology, LLC for the device "ELECTRO INTERSTITIAL SCAN". The FDA issued a decision of Substantially Equivalent on December 10, 2010. The device falls under product code GZO (Device, Galvanic Skin Response Measurement), a Class II device regulated under 21 CFR 882.1540. Ld Technology, LLC has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 10, 2010
Date Received
August 2, 2010
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Device, Galvanic Skin Response Measurement
Device Class
Class II
Regulation Number
882.1540
Review Panel
NE
Submission Type

Other clearances by Ld Technology, LLC

  • K200287 — BP-BT Kiosk (May 15, 2020)
  • K200141 — Oxi-W System (April 27, 2020)
  • K173696 — TBL-ABI System (December 19, 2017)
  • K160956 — LD-Oxi system (July 6, 2016)
  • K152216 — SudoC (September 24, 2015)
  • K143152 — TM-ABI system (July 22, 2015)
  • K140412 — ANS1 SOFTWARE (May 22, 2014)
  • K131568 — SUDO PATH (June 28, 2013)
  • K130056 — PATIENT MONITOR (April 11, 2013)
  • K113264 — ELECTRO SENSOR COMPLEX SOFTWARE (ES COMPLEX SOFTWARE) (March 2, 2012)

Other clearances for product code GZO

  • K150804 — QBioScan (October 19, 2015)
  • K152216 — SudoC (September 24, 2015)
  • K141872 — SUDOSCAN (November 21, 2014)
  • K131568 — SUDO PATH (June 28, 2013)
  • K111308 — ZYTO HAND CRADLE (August 30, 2011)
  • K100233 — SUDOSCAN (June 14, 2010)
  • K053004 — MSAS-VANTAGE (January 13, 2006)
  • K032935 — EPI-SCAN, MODEL P 100 (November 20, 2003)
  • K023355 — ASYRA (June 24, 2003)
  • K020360 — ABR-2000 (August 29, 2002)

FDA data resources