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510(k) K032935

EPI-SCAN, MODEL P 100 by Edx Epi-Scan, Inc. — Product Code GZO

K032935 is an FDA 510(k) premarket notification submitted by Edx Epi-Scan, Inc. for the device "EPI-SCAN, MODEL P 100". The FDA issued a decision of Substantially Equivalent on November 20, 2003. The device falls under product code GZO (Device, Galvanic Skin Response Measurement), a Class II device regulated under 21 CFR 882.1540.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
November 20, 2003
Date Received
September 22, 2003
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 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)
  • K100233 — SUDOSCAN (June 14, 2010)
  • K053004 — MSAS-VANTAGE (January 13, 2006)
  • K023355 — ASYRA (June 24, 2003)
  • K020360 — ABR-2000 (August 29, 2002)

FDA data resources