Bio-Logic Banker
FDA 510(k) K872290 · Bio-Logic Systems Corp.
510(k) numberK872290
Submission
- Device name
- Bio-Logic Banker
- Applicant
- Bio-Logic Systems Corp.
Mudelein, IL, US - Received
- June 16, 1987
- Decision date
- October 6, 1987
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
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| 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 |
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Questions and answers
When was Bio-Logic Banker cleared by the FDA?
Bio-Logic Banker (K872290) received a 510(k) decision of Substantially Equivalent on October 6, 1987, 112 days after the submission was received.
What is the product code of K872290?
The FDA product code is GWK – Conditioner, Signal, Physiological, a Class II (moderate risk) device regulated under 21 CFR 882.1845.