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FDA 510(k)

Neonatal Phototherapy System

K-Number: K200031 · 2020-10-05

ApplicantAvalon Biomedical (Shenzhen) Limited
Decision Date2020-10-05
Product CodeLBI
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

Neonatal Phototherapy System is a medical device manufactured by Avalon Biomedical (Shenzhen) Limited. It received FDA 510(k) clearance on 2020-10-05 under approval number K200031. The device is classified under product code LBI. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Neonatal Phototherapy System?

Neonatal Phototherapy System is a medical device that received FDA 510(k) clearance on 2020-10-05. It is manufactured by Avalon Biomedical (Shenzhen) Limited. The 510(k) number is K200031.

When was Neonatal Phototherapy System approved by the FDA?

Neonatal Phototherapy System received FDA 510(k) clearance on 2020-10-05, under approval number K200031.

What company makes Neonatal Phototherapy System?

Neonatal Phototherapy System is manufactured by Avalon Biomedical (Shenzhen) Limited.

What is the FDA product code for Neonatal Phototherapy System?

The FDA product code for Neonatal Phototherapy System is LBI.

Related Clinical Trials

NCT07610811 Foot Reflexology and Massage in Neonates Receiving Phototherapy NOT_YET_RECRUITING NCT07602036 Type 2 Diabetes and Pregnancy a Single-arm Interventional Study NOT_YET_RECRUITING NCT07409545 Autonomic Nervous System Intrapartum Monitoring to Prevent Neonatal Adverse Outcomes NOT_YET_RECRUITING NCT04956354 The Use of Wireless Sensors in Neonatal Intensive Care ACTIVE_NOT_RECRUITING NCT06693817 Advanced Wireless Sensors for Neonatal Care in the Delivery Room RECRUITING

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Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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