510(k) K120168
K120168 is an FDA 510(k) premarket notification submitted by Wipro GE Healthcare Private, Ltd. for the device "LULLABY LED PHOTTHERAPY SYSTEM". The FDA issued a decision of Substantially Equivalent on May 2, 2012. The device falls under product code LBI (Unit, Neonatal Phototherapy), a Class II device regulated under 21 CFR 880.5700. Wipro GE Healthcare Private, Ltd. has at least 4 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- May 2, 2012
- Date Received
- January 19, 2012
- 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