510(k) K191006
K191006 is an FDA 510(k) premarket notification submitted by Bridge TO Life, Ltd. for the device "EasiSlush". The FDA issued a decision of Substantially Equivalent on September 24, 2019. The device falls under product code KDN (System, Perfusion, Kidney), a Class II device regulated under 21 CFR 876.5880. Bridge TO Life, Ltd. has at least 6 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- September 24, 2019
- Date Received
- April 16, 2019
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- System, Perfusion, Kidney
- Device Class
- Class II
- Regulation Number
- 876.5880
- Review Panel
- GU
- Submission Type