Evoked Potential Sys
FDA 510(k) K842543 · Bio-Logic Systems Corp.
510(k) numberK842543
Submission
- Device name
- Evoked Potential Sys
- Applicant
- Bio-Logic Systems Corp.
Mchenry, IL, US - Received
- July 2, 1984
- Decision date
- November 29, 1984
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
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| K073626 | Bio-Logic Master II Evoked Response SystemGWJ · Special | 02/05/2008SE |
| K061744 | Cochlea-Scan / Cochlea-Scan PlusEWO · Traditional | 09/15/2006SE |
| K052066 | Ceegraph/Sleepscan Netlink TravelerOLV · Special | 08/26/2005SE |
| K031352 | Bio-Logic Insert EarphonesEWO · Traditional | 07/16/2003SE |
| K030907 | Stacked Abr for Navigator ProGWJ · Special | 05/09/2003SE |
| K031009 | Modification to Bio-Logic Evoked Potential (Ep) SystemGWJ · Special | 04/28/2003SE |
| K021895 | Bio-Logic Master Evoked Response SystemGWJ · Special | 07/01/2002SE |
| K021801 | Bio-Logic Abaer Cub with Integrated Oae & Abr FunctionsEWO · Special | 06/27/2002SE |
Questions and answers
When was Evoked Potential Sys cleared by the FDA?
Evoked Potential Sys (K842543) received a 510(k) decision of Substantially Equivalent on November 29, 1984, 150 days after the submission was received.
What is the product code of K842543?
The FDA product code is GWF – Stimulator, Electrical, Evoked Response, a Class II (moderate risk) device regulated under 21 CFR 882.1870.