510(k) K160305
K160305 is an FDA 510(k) premarket notification submitted by Natus Medical Incorporated for the device "neoBLUE® LED Phototherapy System". The FDA issued a decision of Substantially Equivalent on May 27, 2016. The device falls under product code LBI (Unit, Neonatal Phototherapy), a Class II device regulated under 21 CFR 880.5700. Natus Medical Incorporated has at least 9 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- May 27, 2016
- Date Received
- February 4, 2016
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Unit, Neonatal Phototherapy
- Device Class
- Class II
- Regulation Number
- 880.5700
- Review Panel
- HO
- Submission Type