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510(k) K020565

EAV COMBI-2 by Vibrant Health — Product Code GZO

K020565 is an FDA 510(k) premarket notification submitted by Vibrant Health for the device "EAV COMBI-2". The FDA issued a decision of Substantially Equivalent on April 30, 2002. The device falls under product code GZO (Device, Galvanic Skin Response Measurement), a Class II device regulated under 21 CFR 882.1540. Vibrant Health has at least 2 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 30, 2002
Date Received
February 20, 2002
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 Vibrant Health

  • K020567 — AKUPORT M1 (May 2, 2002)
  • K020568 — AKUPORT M-2 (April 30, 2002)

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)
  • K032935 — EPI-SCAN, MODEL P 100 (November 20, 2003)
  • K023355 — ASYRA (June 24, 2003)

FDA data resources