510(k) K010495
K010495 is an FDA 510(k) premarket notification submitted by Medical Illumination International, Inc. for the device "CENTURA PHOTOTHERAPY SPOTLIGHT". The FDA issued a decision of Substantially Equivalent on March 9, 2001. The device falls under product code LBI (Unit, Neonatal Phototherapy), a Class II device regulated under 21 CFR 880.5700. Medical Illumination International, Inc. has at least 4 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- March 9, 2001
- Date Received
- February 20, 2001
- 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