MONOTRODE CUTANEOUS ELECTRODE— 510(k) K915864
Substantially EquivalentHenley Intl.
FDA 510(k) clearance K915864 for MONOTRODE CUTANEOUS ELECTRODE, Substantially Equivalent on 1993-07-21. Applicant: Henley Intl.. Device class: 2.
Clearance details
- Applicant
- Henley Intl.
- 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
- Sugar Land, TX, US
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