BIO-DETEK TRACERITE EEG ELECTRODE— 510(k) K920264
Substantially EquivalentBio-Detek, Inc.
FDA 510(k) clearance K920264 for BIO-DETEK TRACERITE EEG ELECTRODE, Substantially Equivalent on 1992-06-02. Applicant: Bio-Detek, Inc.. Device class: 2.
Clearance details
- Applicant
- Bio-Detek, Inc.
- Product code
- Code GXY
- Device class
- Class 2
- Regulation
- 21 CFR 882.1320
- Advisory panel
- Neurology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Attleboro, MA, US
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