Natus Photic Stimulator
FDA 510(k) K173936 · Natus Medical Incorporated Dba Excel-Tech Ltd. (Xltek)
510(k) numberK173936
Submission
- Device name
- Natus Photic Stimulator
- Applicant
- Natus Medical Incorporated Dba Excel-Tech Ltd. (Xltek)
Oakville, CA - Received
- December 26, 2017
- Decision date
- June 15, 2018
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
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Questions and answers
When was Natus Photic Stimulator cleared by the FDA?
Natus Photic Stimulator (K173936) received a 510(k) decision of Substantially Equivalent on June 15, 2018, 171 days after the submission was received.
What is the product code of K173936?
The FDA product code is GWE – Stimulator, Photic, Evoked Response, a Class II (moderate risk) device regulated under 21 CFR 882.1890.