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510(k) K152216

SudoC by Ld Technology, LLC — Product Code GZO

K152216 is an FDA 510(k) premarket notification submitted by Ld Technology, LLC for the device "SudoC". The FDA issued a decision of Substantially Equivalent on September 24, 2015. 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
September 24, 2015
Date Received
August 7, 2015
Clearance Type
Special
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)
  • 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)
  • K103026 — ELECTRO SENSOR -BODY COMPOSITION (March 29, 2011)

Other clearances for product code GZO

  • K150804 — QBioScan (October 19, 2015)
  • K141872 — SUDOSCAN (November 21, 2014)
  • K131568 — SUDO PATH (June 28, 2013)
  • K111308 — ZYTO HAND CRADLE (August 30, 2011)
  • K102166 — ELECTRO INTERSTITIAL SCAN (December 10, 2010)
  • 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