Sudoscan
FDA 510(k) K141872 · Impeto Medical, Inc.
510(k) numberK141872
Submission
- Device name
- Sudoscan
- Applicant
- Impeto Medical, Inc.
Alexandria, VA, US - Received
- July 11, 2014
- Decision date
- November 21, 2014
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Other 510(k)s with product code GZO
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K150804 | QBioScanGZO · Traditional | Medeia, Inc. | 10/19/2015SE |
| K152216 | SudoCGZO · Special | Ld Technology, LLC | 09/24/2015SE |
| K131568 | Sudo PathGZO · Special | Ld Technology, LLC | 06/28/2013SE |
| K111308 | Zyto Hand CradleGZO · Traditional | Zyto Technologies, Inc. | 08/30/2011SE |
| K102166 | Electro Interstitial ScanGZO · Traditional | Ld Technology, LLC | 12/10/2010SE |
| K100233 | SudoscanGZO · Traditional | Impeto Medical | 06/14/2010SE |
| K053004 | Msas-VantageGZO · Special | Biomeridian, Int. | 01/13/2006SE |
| K032935 | Epi-Scan, Model P 100GZO · Special | Edx Epi-Scan, Inc. | 11/20/2003SE |
| K023355 | AsyraGZO · Traditional | Galloway Technologies, LLC | 06/24/2003SE |
| K020360 | ABR-2000GZO · Traditional | Meridian Co., Ltd. | 08/29/2002SE |
More from Meridian Co., Ltd.
| 510(k) | Device | Decision |
|---|---|---|
| K100233 | SudoscanGZO · Traditional | 06/14/2010SE |
Questions and answers
When was Sudoscan cleared by the FDA?
Sudoscan (K141872) received a 510(k) decision of Substantially Equivalent on November 21, 2014, 133 days after the submission was received.
What is the product code of K141872?
The FDA product code is GZO – Device, Galvanic Skin Response Measurement, a Class II (moderate risk) device regulated under 21 CFR 882.1540.