Home / 510(k) Clearances / K100233

510(k) K100233

SUDOSCAN by Impeto Medical — Product Code GZO

K100233 is an FDA 510(k) premarket notification submitted by Impeto Medical for the device "SUDOSCAN". The FDA issued a decision of Substantially Equivalent on June 14, 2010. The device falls under product code GZO (Device, Galvanic Skin Response Measurement), a Class II device regulated under 21 CFR 882.1540. Impeto Medical has at least 1 other 510(k) clearance on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 14, 2010
Date Received
January 26, 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 Impeto Medical

  • K141872 — SUDOSCAN (November 21, 2014)

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)
  • K102166 — ELECTRO INTERSTITIAL SCAN (December 10, 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