510(k) K093618
K093618 is an FDA 510(k) premarket notification submitted by Physician Engineered Products, Inc. for the device "BILI-MIRROR MODEL BLM-1". The FDA issued a decision of Substantially Equivalent on April 23, 2010. 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
- April 23, 2010
- Date Received
- November 23, 2009
- 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