Multi-Signal Auditory Stimulator SM700
FDA 510(k) K830579 · Nicolet Biomedical Instruments
510(k) numberK830579
Submission
- Device name
- Multi-Signal Auditory Stimulator SM700
- Applicant
- Nicolet Biomedical Instruments
Mchenry, IL, US - Received
- February 23, 1983
- Decision date
- March 8, 1983
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
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Questions and answers
When was Multi-Signal Auditory Stimulator SM700 cleared by the FDA?
Multi-Signal Auditory Stimulator SM700 (K830579) received a 510(k) decision of Substantially Equivalent on March 8, 1983, 13 days after the submission was received.
What is the product code of K830579?
The FDA product code is GWJ – Stimulator, Auditory, Evoked Response, a Class II (moderate risk) device regulated under 21 CFR 882.1900.