Phazx VLD-100

FDA 510(k) K992129 · Phazx Systems, Inc.

Substantially Equivalent

510(k) numberK992129

Submission

Device name
Phazx VLD-100
Applicant
Phazx Systems, Inc.
Boulder, CO, US
Received
June 23, 1999
Decision date
September 17, 1999
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)
Summary
510(k) statement 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

510(k)DeviceApplicantDecision
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
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

Questions and answers

When was Phazx VLD-100 cleared by the FDA?

Phazx VLD-100 (K992129) received a 510(k) decision of Substantially Equivalent on September 17, 1999, 86 days after the submission was received.

What is the product code of K992129?

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