510(k) K970436
- Device
- E-READER
- Applicant
- NATURAL HERBAL PRODUCTS, INC.
- 510(k) number
- K970436
- Product code
- GZO
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 1997-08-15
- Date received
- 1997-02-05
- Regulation
- 882.1540
- Classification name
- Device, Galvanic Skin Response Measurement
- Medical specialty
- Neurology
- Review panel
- Neurology
- Device class
- 2
- Clearance type
- Traditional
- Statement or summary
- Statement
- Third party reviewed
- No
Applicant Contact#
- Address
- 724 Wiggins Bay Dr. Naples FL US 34110 34110
FDA Registration Numbers#
- 2080783
- 3008820594
- 3010078139
- 3008717264
- 3014757803
- 3008493238
- 3013501110
- 3010806878
- 3012933969
- 3013037032
- 3007048291
- 3013896610
- 3008496197
- 3007962724
- 8030229
- 3004545755
- 3013689228
- 3010536822
- 3008485370
- 3016159413
- 9611252
- 3016852448
- 3033715634
- 3006146787
- 3013755083
- 3012302888
- 3020018
Source Documents#
510(k) summary PDF not indicated by FDA
Other 510(k) Records For Product Code GZO #
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K150804 | QBioScan | Medeia, Inc. | 2015-10-19 |
| K152216 | SudoC | Ld Technology, LLC | 2015-09-24 |
| K141872 | SUDOSCAN | Impeto Medical, Inc. | 2014-11-21 |
| K131568 | SUDO PATH | Ld Technology, LLC | 2013-06-28 |
| K111308 | ZYTO HAND CRADLE | Zyto Technologies, Inc. | 2011-08-30 |
| K102166 | ELECTRO INTERSTITIAL SCAN | Ld Technology, LLC | 2010-12-10 |
| K100233 | SUDOSCAN | Impeto Medical | 2010-06-14 |
| K053004 | MSAS-VANTAGE | Biomeridian, Int. | 2006-01-13 |
| K032935 | EPI-SCAN, MODEL P 100 | Edx Epi-Scan, Inc. | 2003-11-20 |
| K023355 | ASYRA | Galloway Technologies, LLC | 2003-06-24 |
| K020360 | ABR-2000 | Meridian Co., Ltd. | 2002-08-29 |
| K020567 | AKUPORT M1 | Vibrant Health | 2002-05-02 |
| K020564 | EAV KINDLING 2000S GSR DEVICE | Virbrant Health | 2002-04-30 |
| K020565 | EAV COMBI-2 | Vibrant Health | 2002-04-30 |
| K020568 | AKUPORT M-2 | Vibrant Health | 2002-04-30 |
Legacy Summary#
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FDA Review#
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