BIO-DETEK EEG ELECTRODE— 510(k) K920352
Substantially EquivalentBio-Detek, Inc.
FDA 510(k) clearance K920352 for BIO-DETEK EEG ELECTRODE, Substantially Equivalent on 1992-08-14. Applicant: Bio-Detek, Inc.. Device class: 2.
Clearance details
- Applicant
- Bio-Detek, Inc.
- Product code
- Code GXZ
- Device class
- Class 2
- Regulation
- 21 CFR 882.1350
- Advisory panel
- Neurology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Attleboro, MA, US
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