Pixie Pulse (SM9068)— 510(k) K241365
Substantially EquivalentPixie Cup, LLC
FDA 510(k) clearance K241365 for Pixie Pulse (SM9068), Substantially Equivalent on 2024-08-12. Applicant: Pixie Cup, LLC. Device class: 2.
Clearance details
- Applicant
- Pixie Cup, LLC
- Product code
- Code NUH
- Device class
- Class 2
- Regulation
- 21 CFR 882.5890
- Advisory panel
- Neurology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Walnut Shade, MO, US
Recent devices under product code NUH
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