510(k) K160238
K160238 is an FDA 510(k) premarket notification submitted by International Biomedical for the device "Airborne Phototherapy Light". The FDA issued a decision of Substantially Equivalent on June 14, 2016. The device falls under product code LBI (Unit, Neonatal Phototherapy), a Class II device regulated under 21 CFR 880.5700. International Biomedical has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- June 14, 2016
- Date Received
- February 1, 2016
- Clearance Type
- Abbreviated
- 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