NEUROLUMEN PN-1000— 510(k) K142025
Substantially EquivalentNeurolumen, LLC
FDA 510(k) clearance K142025 for NEUROLUMEN PN-1000, Substantially Equivalent on 2015-01-21. Applicant: Neurolumen, LLC. Device class: 2.
Clearance details
- Applicant
- Neurolumen, LLC
- Product code
- Code ILY
- Device class
- Class 2
- Regulation
- 21 CFR 890.5500
- Advisory panel
- Physical Medicine
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Oklahoma City, OK, US
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More clearances from Neurolumen, LLC
view allAdverse events under product code ILY
product code ILY- Death
- 3
- Total
- 3
Source: openFDA MAUDE database, through . Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →
Data sourced from openFDA. This site is unofficial and independent of the FDA.