Luminice— 510(k) K214100
Substantially EquivalentPremier North America, Inc.
FDA 510(k) clearance K214100 for Luminice, Substantially Equivalent on 2022-02-24. Applicant: Premier North America, Inc.. Device class: 2.
Clearance details
- Applicant
- Premier North America, Inc.
- Product code
- Code NFO
- Device class
- Class 2
- Regulation
- 21 CFR 882.5890
- Advisory panel
- Neurology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Fort Lauderdale, FL, US
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