Excel Photic Stimulator, Model (XLPS-1)
FDA 510(k) K991903 · Excel Tech. , Ltd.
510(k) numberK991903
Submission
- Device name
- Excel Photic Stimulator, Model (XLPS-1)
- Applicant
- Excel Tech. , Ltd.
Oakville,Ontario, CA - Received
- June 4, 1999
- Decision date
- August 4, 1999
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) statement available from FDA
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Questions and answers
When was Excel Photic Stimulator, Model (XLPS-1) cleared by the FDA?
Excel Photic Stimulator, Model (XLPS-1) (K991903) received a 510(k) decision of Substantially Equivalent on August 4, 1999, 61 days after the submission was received.
What is the product code of K991903?
The FDA product code is GWE – Stimulator, Photic, Evoked Response, a Class II (moderate risk) device regulated under 21 CFR 882.1890.