GUARDIAN 150 ELECTRODE— 510(k) K083756
Substantially EquivalentSelectivemed Components, Inc.
FDA 510(k) clearance K083756 for GUARDIAN 150 ELECTRODE, Substantially Equivalent on 2009-06-26. Applicant: Selectivemed Components, Inc.. Device class: 2.
Clearance details
- Applicant
- Selectivemed Components, 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
- Roswell, GA, US
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