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510(k) K020567

AKUPORT M1 by Vibrant Health — Product Code GZO

K020567 is an FDA 510(k) premarket notification submitted by Vibrant Health for the device "AKUPORT M1". The FDA issued a decision of Substantially Equivalent on May 2, 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
May 2, 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

  • K020565 — EAV COMBI-2 (April 30, 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