Home / 510(k) Clearances / K111308

510(k) K111308

ZYTO HAND CRADLE by Zyto Technologies, Inc. — Product Code GZO

K111308 is an FDA 510(k) premarket notification submitted by Zyto Technologies, Inc. for the device "ZYTO HAND CRADLE". The FDA issued a decision of Substantially Equivalent on August 30, 2011. 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
August 30, 2011
Date Received
May 10, 2011
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 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)
  • 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