510(k) K120104
K120104 is an FDA 510(k) premarket notification submitted by Visionsearch Pty, Ltd. for the device "VISIONSEARCH 1". The FDA issued a decision of Substantially Equivalent on May 21, 2012. The device falls under product code GWE (Stimulator, Photic, Evoked Response), a Class II device regulated under 21 CFR 882.1890.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- May 21, 2012
- Date Received
- January 13, 2012
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- Yes
Device Classification
- Device Name
- Stimulator, Photic, Evoked Response
- Device Class
- Class II
- Regulation Number
- 882.1890
- Review Panel
- NE
- Submission Type