510(k) K142416
K142416 is an FDA 510(k) premarket notification submitted by Salter Labs for the device "Luma Wrap". The FDA issued a decision of Substantially Equivalent on June 12, 2015. The device falls under product code PDH (Blanket, Neonatal Phototherapy), a Class II device regulated under 21 CFR 880.5700. Salter Labs has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- June 12, 2015
- Date Received
- August 28, 2014
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Blanket, Neonatal Phototherapy
- Device Class
- Class II
- Regulation Number
- 880.5700
- Review Panel
- HO
- Submission Type
Is intended to be used as an adjunct to neonatal phototherapy systems used for the treatment of neonatal hyperbilirubinemia in the clinical or home setting.