Sudo Path

FDA 510(k) K131568 · Ld Technology, LLC

Substantially Equivalent

510(k) numberK131568

Submission

Device name
Sudo Path
Applicant
Ld Technology, LLC
Miami, FL, US
Received
May 30, 2013
Decision date
June 28, 2013
Decision
Substantially Equivalent (SESE)
Type
Special 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
K111308Zyto Hand CradleGZO · Traditional Zyto Technologies, Inc.08/30/2011SE
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

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Questions and answers

When was Sudo Path cleared by the FDA?

Sudo Path (K131568) received a 510(k) decision of Substantially Equivalent on June 28, 2013, 29 days after the submission was received.

What is the product code of K131568?

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