ManaFlexx 2 (model: MF002-RX, MF002-OTC)— 510(k) K231569
Substantially EquivalentManamed, Inc.
FDA 510(k) clearance K231569 for ManaFlexx 2 (model: MF002-RX, MF002-OTC), Substantially Equivalent on 2023-11-03. Applicant: Manamed, Inc.. Device class: 2.
Clearance details
- Applicant
- Manamed, Inc.
- 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
- Las Vegas, NV, US
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