EIM-107 Prep-Check
FDA 510(k) K993202 · General Devices
510(k) numberK993202
Submission
- Device name
- EIM-107 Prep-Check
- Applicant
- General Devices
Ridgefield, NJ, US - Received
- September 24, 1999
- Decision date
- December 17, 1999
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) statement 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 |
| K141872 | SudoscanGZO · Traditional | Impeto Medical, Inc. | 11/21/2014SE |
| 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 |
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| K940009 | Gemscom Series 6000, Models 6100, 6200 & 6300DRG · Traditional | 04/14/1995SE |
| K935839 | Gemscom Series 5000,DRG · Traditional | 11/10/1994SE |
| K921929 | Gemscom Series 300 12-LEAD ECG (12-LEAD Option)DXH · Traditional | 09/18/1992SE |
| K914889 | Gemscom Series 3000DRG · Traditional | 03/04/1992SE |
| K912008 | Tru-View Multi-Channel DisplayDRT · Traditional | 10/09/1991SE |
| K896153 | Modified DR-2C/PMC 100DSH · Traditional | 01/19/1990SE |
| K862596 | DR-2C (Modification)DSF · Traditional | 09/26/1986SE |
| K844650 | DR-2CDXJ · Traditional | 01/22/1985SE |
Questions and answers
When was EIM-107 Prep-Check cleared by the FDA?
EIM-107 Prep-Check (K993202) received a 510(k) decision of Substantially Equivalent on December 17, 1999, 84 days after the submission was received.
What is the product code of K993202?
The FDA product code is GZO – Device, Galvanic Skin Response Measurement, a Class II (moderate risk) device regulated under 21 CFR 882.1540.