510(k) K252514
K252514 is an FDA 510(k) premarket notification submitted by Phasor Health, LLC for the device "EVAC-MRI". The FDA issued a decision of Substantially Equivalent (with conditions) on November 5, 2025. The device falls under product code JXG (Shunt, Central Nervous System And Components), a Class II device regulated under 21 CFR 882.5550. Phasor Health, LLC has at least 4 other 510(k) clearances on record.
Clearance Details
- Decision
- SESD (Substantially Equivalent (with conditions))
- Decision Date
- November 5, 2025
- Date Received
- August 11, 2025
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Shunt, Central Nervous System And Components
- Device Class
- Class II
- Regulation Number
- 882.5550
- Review Panel
- NE
- Submission Type