L.E.D. GOGGLES, MODEL 580-LEDGOG
FDA 510(k) clearance K852533 · decided 1985-12-12
Clearance details
- K-number
- K852533
- Device name
- L.E.D. GOGGLES, MODEL 580-LEDGOG
- Applicant
- Bio-Logic Systems Corp.
- Decision
- Substantially Equivalent
- Date received
- 1985-06-14
- Decision date
- 1985-12-12
- Days to decision
- 181 days
- Clearance type
- Traditional
- Product code
- GWE
- Device class
- 2
- Regulation number
- 882.1890
- Medical specialty
- Neurology
- Advisory committee
- Neurology
- Location
- Northbrook, IL, US
- Third-party review
- No
- Expedited review
- No
+ Add to Predicate Builder ◉ Watch Bio-Logic Systems Corp.
Need this as data, not a web page?
Query all 176,000+ clearances through the Atlas FDA API, or subscribe to weekly change alerts. Self-serve from $29/mo.
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 |
| Vision Monitor- MonCvONE (K212936) | Metrovision | 2022-11-21 |
| 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 |
Recalls involving this device
No recalls on record reference this clearance.