510(k) K043367
K043367 is an FDA 510(k) premarket notification submitted by Lace Electronica S.R.L. for the device "GLAID OCULAR ELECTROPHYSIOLOGY DEVICE". The FDA issued a decision of Substantially Equivalent on Nov 17, 2005. 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
- Nov 17, 2005
- Date Received
- Dec 8, 2004
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Stimulator, Photic, Evoked Response
- Device Class
- Class II
- Regulation Number
- 882.1890
- Review Panel
- NE
- Submission Type
- 510(k)