Zyto Hand Cradle

FDA 510(k) K111308 · Zyto Technologies, Inc.

Substantially Equivalent

510(k) numberK111308

Submission

Device name
Zyto Hand Cradle
Applicant
Zyto Technologies, Inc.
Lindon, UT, US
Received
May 10, 2011
Decision date
August 30, 2011
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)
Summary
510(k) summary available from FDA

Official FDA 510(k) record

Device classification

Product code
GZO – Device, Galvanic Skin Response Measurement
Device class
Class II (moderate risk)
Regulation
21 CFR 882.1540
Specialty
Neurology

Other 510(k)s with product code GZO

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K150804QBioScanGZO · Traditional Medeia, Inc.10/19/2015SE
K152216SudoCGZO · Special Ld Technology, LLC09/24/2015SE
K141872SudoscanGZO · Traditional Impeto Medical, Inc.11/21/2014SE
K131568Sudo PathGZO · Special Ld Technology, LLC06/28/2013SE
K102166Electro Interstitial ScanGZO · Traditional Ld Technology, LLC12/10/2010SE
K100233SudoscanGZO · Traditional Impeto Medical06/14/2010SE
K053004Msas-VantageGZO · Special Biomeridian, Int.01/13/2006SE
K032935Epi-Scan, Model P 100GZO · Special Edx Epi-Scan, Inc.11/20/2003SE
K023355AsyraGZO · Traditional Galloway Technologies, LLC06/24/2003SE
K020360ABR-2000GZO · Traditional Meridian Co., Ltd.08/29/2002SE

Questions and answers

When was Zyto Hand Cradle cleared by the FDA?

Zyto Hand Cradle (K111308) received a 510(k) decision of Substantially Equivalent on August 30, 2011, 112 days after the submission was received.

What is the product code of K111308?

The FDA product code is GZO – Device, Galvanic Skin Response Measurement, a Class II (moderate risk) device regulated under 21 CFR 882.1540.