510(k) K110550
K110550 is an FDA 510(k) premarket notification submitted by Physician Engineered Products, Inc. for the device "BRIGHT EMBRACE MODEL SBL60". The FDA issued a decision of Substantially Equivalent on February 3, 2012. The device falls under product code LBI (Unit, Neonatal Phototherapy), a Class II device regulated under 21 CFR 880.5700. Physician Engineered Products, Inc. has at least 7 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- February 3, 2012
- Date Received
- February 25, 2011
- 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