Bio-Logic Master Evoked Response System
FDA 510(k) K021895 · Bio-Logic Systems Corp.
510(k) numberK021895
Submission
- Device name
- Bio-Logic Master Evoked Response System
- Applicant
- Bio-Logic Systems Corp.
Mudelein, IL, US - Received
- June 10, 2002
- Decision date
- July 1, 2002
- Decision
- Substantially Equivalent (SESE)
- Type
- Special 510(k)
- Summary
- 510(k) summary available from FDA
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| K031009 | Modification to Bio-Logic Evoked Potential (Ep) SystemGWJ · Special | 04/28/2003SE |
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Questions and answers
When was Bio-Logic Master Evoked Response System cleared by the FDA?
Bio-Logic Master Evoked Response System (K021895) received a 510(k) decision of Substantially Equivalent on July 1, 2002, 21 days after the submission was received.
What is the product code of K021895?
The FDA product code is GWJ – Stimulator, Auditory, Evoked Response, a Class II (moderate risk) device regulated under 21 CFR 882.1900.