E-Reader

FDA 510(k) K970436 · Natural Herbal Products, Inc.

Substantially Equivalent

510(k) numberK970436

Submission

Device name
E-Reader
Applicant
Natural Herbal Products, Inc.
Naples, FL, US
Received
February 5, 1997
Decision date
August 15, 1997
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 E-Reader cleared by the FDA?

E-Reader (K970436) received a 510(k) decision of Substantially Equivalent on August 15, 1997, 191 days after the submission was received.

What is the product code of K970436?

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