Vision Monitor- MonCvONE
FDA 510(k) clearance K212936 · decided 2022-11-21
Clearance details
- K-number
- K212936
- Device name
- Vision Monitor- MonCvONE
- Applicant
- Metrovision
- Decision
- Substantially Equivalent
- Date received
- 2021-09-15
- Decision date
- 2022-11-21
- Days to decision
- 432 days
- Clearance type
- Traditional
- Product code
- GWE
- Device class
- 2
- Regulation number
- 882.1890
- Medical specialty
- Neurology
- Advisory committee
- Neurology
- Location
- Perenchies, FR
- Third-party review
- No
- Expedited review
- No
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Similar devices under this product code
Devices cleared under the same product code - the starting set for predicate research.
| Record | Firm | Date |
|---|---|---|
| E3 and Profile (K221471) | Diagnosys, LLC | 2022-11-22 |
| LED PHOTIC System (K211974) | Micromed S.P.A. | 2021-09-23 |
| Vision Monitor - MonpackONE (K211643) | Metrovision | 2021-07-26 |
| Nurochek System (K200705) | Cryptych Pty, Ltd. | 2020-04-23 |
| Natus Photic Stimulator (K173936) | Natus Medical Incorporated Dba Excel-Tech Ltd. (Xltek) | 2018-06-15 |
| RETeval Visual Electrodiagnostic Device (K142567) | Lkc Technologies, Inc. | 2015-05-19 |
| ADHERENT VISUAL STIMULATOR GOGGLES (K113785) | Anschel Technology, Inc. | 2012-06-06 |
| VISIONSEARCH 1 (K120104) | Visionsearch Pty, Ltd. | 2012-05-21 |
| DIOPSYS NOVA VEP VISION TESTING SYSTEM (K101763) | Diopsys, Inc. | 2011-05-09 |
| LIFELINES PHOTIC STIMULATOR (K101691) | Lifelines , Ltd. | 2010-08-10 |
| NEUCODIA (K081591) | Verisci Corporation | 2009-05-15 |
| GLAID OCULAR ELECTROPHYSIOLOGY DEVICE (K043367) | Lace Electronica S.R.L. | 2005-11-17 |
Recalls involving this device
No recalls on record reference this clearance.