510(k) K991903
K991903 is an FDA 510(k) premarket notification submitted by Excel Tech. , Ltd. for the device "EXCEL PHOTIC STIMULATOR, MODEL (XLPS-1)". The FDA issued a decision of Substantially Equivalent on Aug 4, 1999. The device falls under product code GWE (Stimulator, Photic, Evoked Response), a Class II device regulated under 21 CFR 882.1890. Excel Tech. , Ltd. has 57 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- Aug 4, 1999
- Date Received
- Jun 4, 1999
- 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)