MR Conditional Cup Electrode, MR Conditional Webb Electrode— 510(k) K172503
Substantially EquivalentRhythmlink International, LLC
FDA 510(k) clearance K172503 for MR Conditional Cup Electrode, MR Conditional Webb Electrode, Substantially Equivalent on 2017-12-01. Applicant: Rhythmlink International, LLC. Device class: 2.
Clearance details
- Applicant
- Rhythmlink International, LLC
- 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
- Columbia, SC, US
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More clearances from Rhythmlink International, LLC
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