E3 and Profile
FDA 510(k) K221471 · Diagnosys, LLC
510(k) numberK221471
Submission
- Device name
- E3 and Profile
- Applicant
- Diagnosys, LLC
Lowell, MA, US - Received
- May 20, 2022
- Decision date
- November 22, 2022
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Other 510(k)s with product code GWE
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K212936 | Vision Monitor- MonCvONEGWE · Traditional | Metrovision | 11/21/2022SE |
| K211974 | LED PHOTIC SystemGWE · Traditional | Micromed S.P.A. | 09/23/2021SE |
| K211643 | Vision Monitor - MonpackONEGWE · Traditional | Metrovision | 07/26/2021SE |
| K200705 | Nurochek SystemGWE · Traditional | Cryptych Pty, Ltd. | 04/23/2020SE |
| K173936 | Natus Photic StimulatorGWE · Traditional | Natus Medical Incorporated Dba Excel-Tech Ltd.… | 06/15/2018SE |
| K142567 | RETeval Visual Electrodiagnostic DeviceGWE · Traditional | Lkc Technologies, Inc. | 05/19/2015SE |
| K113785 | Adherent Visual Stimulator GogglesGWE · Traditional | Anschel Technology, Inc. | 06/06/2012SE |
| K120104 | Visionsearch 1GWE · Traditional | Visionsearch Pty, Ltd. | 05/21/2012SE |
| K101763 | Diopsys Nova Vep Vision Testing SystemGWE · Traditional | Diopsys, Inc. | 05/09/2011SE |
| K101691 | Lifelines Photic StimulatorGWE · Traditional | Lifelines , Ltd. | 08/10/2010SE |
Questions and answers
When was E3 and Profile cleared by the FDA?
E3 and Profile (K221471) received a 510(k) decision of Substantially Equivalent on November 22, 2022, 186 days after the submission was received.
What is the product code of K221471?
The FDA product code is GWE – Stimulator, Photic, Evoked Response, a Class II (moderate risk) device regulated under 21 CFR 882.1890.