510(k) K210289
K210289 is an FDA 510(k) premarket notification submitted by Bistos Co., Ltd. for the device "Infant Phototherapy Equipment". The FDA issued a decision of Substantially Equivalent on May 28, 2021. The device falls under product code LBI (Unit, Neonatal Phototherapy), a Class II device regulated under 21 CFR 880.5700. Bistos Co., Ltd. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- May 28, 2021
- Date Received
- February 2, 2021
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- Yes
Device Classification
- Device Name
- Unit, Neonatal Phototherapy
- Device Class
- Class II
- Regulation Number
- 880.5700
- Review Panel
- HO
- Submission Type