VISIONSEARCH 1
FDA 510(k) clearance K120104 · decided 2012-05-21
Clearance details
- K-number
- K120104
- Device name
- VISIONSEARCH 1
- Applicant
- Visionsearch Pty, Ltd.
- Decision
- Substantially Equivalent
- Date received
- 2012-01-13
- Decision date
- 2012-05-21
- Days to decision
- 129 days
- Clearance type
- Traditional
- Product code
- GWE
- Device class
- 2
- Regulation number
- 882.1890
- Medical specialty
- Neurology
- Advisory committee
- Neurology
- Location
- St Leonards, AU
- Third-party review
- Yes
- Expedited review
- No
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| RETeval Visual Electrodiagnostic Device (K142567) | Lkc Technologies, Inc. | 2015-05-19 |
| ADHERENT VISUAL STIMULATOR GOGGLES (K113785) | Anschel Technology, Inc. | 2012-06-06 |
| 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 |
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Recalls involving this device
No recalls on record reference this clearance.